דרושים Project Architect ב-United States

West Pharma Quality Project Manager United States, Pennsylvania, West Whiteland Township

Limitless High-tech career opportunities - Expoint

שיתוף

Lead the initiative to standardize quality systems between multiple sites. Identify best practices and ensure roll out to relevant sites. Organize and generate detailed quality information reports to show trends...

Essential Duties and Responsibilities

Job Summary

In this role, the Quality Project Manager will support the standardization of QMS process and data management across the organization. This position will lead the development and deployment of quality maturity, QMS improvements and quality cost related measures, evaluations, performance, and initiatives. This position will coordinate activities associated with quality maturity including continuous improvement projects relating to sustaining engineering activities, development of new methods/processes for product evaluation and product development activities through a standardized approach. In addition, this position will deploy highly capable, predictive, effective, and efficient quality cost metrics for West Pharmaceuticals. This position will also be responsible for leading and executing cost improvement initiatives, follow up assessments and action oversight.

Lead the initiative to standardize quality systems between multiple sites. Identify best practices and ensure roll out to relevant sites.
Organize and generate detailed quality information reports to show trends and the impact of process improvements.
Create repeatable methods to assess, measure and communicate the overall quality of a project and deliver key metrics to assess the overall improvement.
Establish and lead cross functional quality related meetings to review and discuss performance, status and prompting necessary actions as required.
Manage goals and metrics for Quality teams/initiatives to adequately monitor the overall effectiveness of the teams/initiatives.
Work with project managers, engineering team, and platform management to develop plans to implement improvement projects.
Ensures teams work closely with product development, supplier/contractors, design, quality, regulatory teams in order to establish standardized KPIs.
Work within Quality or across West Divisions to triage Customer Operational difficulties, define root cause(s), and coordinate the implementation of corrective and preventive actions to preclude recurrence related to quality improvements and quality maturity.
Manage or contribute to both corporate and facility driven initiatives intended to meet defined objectives.
Support front room and or backroom responsibilities during external audits. Including post audit activities, if required.
Responsible for assembling a project team, assigning individual responsibilities, identifying appropriate resources needed, and developing schedules to ensure timely completion of project.
Record detailed customer requirements, constraints, and assumptions with stakeholders in order to establish the project deliverables.
Responsible for project budget estimation, monitoring, and attainment throughout the project lifecycle.
Ensure a common understanding by setting expectations in accordance with the project plan in order to align the stakeholders and team members.
Lead the identification, assessment, monitoring, and closure of project risks throughout the project lifecycle.
Manage changes to the project scope, project schedule, and project costs using appropriate verification techniques in order to keep the project plan accurate, updated, and reflective of authorized changes to facilitate customer acceptance.
Responsible to improve team performance by building team cohesiveness, leading and motivating in order to facilitate cooperation, ensure project efficiency, and boost morale.
Measure project performance using appropriate tools and techniques in order to monitor the progress of the project, identify and quantify any variances, perform any required corrective actions, and communicate to all stakeholders.
May coordinate the activities of one or more exempt and/or non-exempt employees.
All other duties as required.

Education

Bachelor's Degree in Science, Engineering or related field

Work Experience

8+ years of relevant work experience required

Preferred Knowledge, Skills and Abilities

5+ years’ experience in pharmaceutical or medical device environment.
2+ years’ experience in a Quality role.
ASQ CQE certification desirable.
Deep knowledge of quality processes such as CAPA, complaint management, risk management, root cause analysis, statistical sampling plans, FMEA/Fault Tree Analysis, Design Optimization using DOE, Hardware Reliability, Software Reliability, and Design Controls including Design Verification/Validation.
Knowledge of ISO 9001:2008, ISO 13485, 21 CFR 820, 21 CFR 210 & 211, cGMP, cGLP.
Ability to manage direct report(s), work independently and in a team environment.
Demonstrate innovativeness in tactical matters relating to proposing alternate solutions for process improvement.
Experience in FDA regulated environment, pertinent to ISO 13485 is preferred.
Experience with SAP is preferred.
Support and contribute to Lean Sigma programs and activities towards delivery of the set target.
Able to comply with the company’s safety policy at all times.
Able to comply with the company’s quality policy at all times.

Physical Requirements

Sedentary-Exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time.

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MDB

MongoDB Senior Solutions Architect United States, California, San Francisco

שיתוף

Ideally 8 to 11 years of related experience in a customer facing role, with 5 to 7 years of experience in pre-sales with enterprise software. Minimum of 3 years experience...

As an ideal candidate, you will have

Ideally 8 to 11 years of related experience in a customer facing role, with 5 to 7 years of experience in pre-sales with enterprise software
Minimum of 3 years experience with modern scripting languages (e.g. Python, Node.js, SQL) and/or popular programming languages (e.g. C/C++, Java, C#) in a professional capacity
Experience designing with scalable and highly available distributed systems in the cloud and on-prem
Demonstrated ability to work with customers to review complex architecture of existing applications, providing guidance on how to improve by leveraging technology
Excellent presentation, communication, and interpersonal skills, with the ability to convey complex technical and business concepts in a clear and compelling manner to technology and business leadership
Ability to strategize with sales teams and provide recommendations on how to drive a multi-threaded account strategy, aligning other MongoDB and ecosystem resources to move towards a mutually beneficial account plan
The ability to travel up to 25%
A Bachelor’s degree or equivalent work experience

You may also have

Experience selling databases and/or deploying applications with any of the major cloud providers
Experience with database programming and data models
Experience in data engineering or AI/ML projects
Experience in transforming legacy systems and platforms into modern, scalable, and efficient technology stacks
Understanding of popular sales methodologies/ frameworks such as MEDDPICC/Command of the Message
A MongoDB Certification
A Cloud Provider Certification

In this role, you will work on complex opportunities where analysis of situations or data requires an in-depth evaluation of various factors. You will:

Design and Architect: Design scalable and performant applications, systems and infrastructure for large software projects leveraging MongoDB
Customer Advising and Value Articulation: Guide customers on architecture patterns and optimisation strategies for MongoDB, while clearly communicating its business value to the relevant stakeholders
Sales Partnership: Collaborate with the sales team to drive account success through account planning, opportunity prioritization/qualification and pipeline generation strategy, while taking ownership of the technical aspects (including but not limited to technical discovery, demos, proof of value, presentations, sizing and documentation)
Demand Generation: Proactively generate demand within the sales territory through self-driven technical initiatives, participation in events such as industry trade shows and account-based marketing events
Customer Success: Foster strong customer relationships, build champions and ensure customer success and satisfaction
Innovation and Improvement: Continuously seek opportunities to innovate and improve MongoDB solutions and processes (e.g. by relaying field feedback to the product team), as well as proactively mentor other Solutions Consulting team members
Personal Training and Development: Engage in ongoing training and professional development to stay abreast of MongoDB product suite as well as industry trends

What you will learn

MongoDB Product Suite Mastery

Core Database Server: Master the fundamentals and advanced features of MongoDB's core database
Atlas and Advanced Services: Gain expertise in Atlas (fully managed cloud database service), Atlas Stream Processing, Atlas Data Lake, Atlas Full-Text Search, Atlas Vector Search, and Charts
Relational Migrator: Learn to migrate from relational databases seamlessly

Market-Relevant Technologies

Hyperscaler Ecosystem: Gain expertise in designing complex systems utilizing cloud services on hyperscaler platforms
Complementary Technologies: Enhance your skills with partner and complementary technologies such as Apache Kafka and Kubernetes

Modern Architecture Design

Design Patterns and Methodologies: Embrace best practices in microservices, DevOps, cloud, and security
Cutting Edge RAG and AI Architectures: Help customers on their generative AI journeys and working with industry leading partners in the space

Sales Techniques and Soft Skills

Effective Communication: Master presentations, demonstrations, and whiteboarding
Client Interaction: Develop strategies for discovery and objection handling

Industry Insights

Diverse Market Verticals: Gain exposure to a broad spectrum of interesting use cases across various industries

$204,000 USD

משרות נוספות שיכולות לעניין אותך

Informatica Technical Support Architect - United States, Texas, Austin

שיתוף

Expert level knowledge on Informatica Master Data Management product suite required. Experience in a Pre-sales or Post-sales consulting role, preferably in Enterprise software solutions (MDM, Data Integration, Data Quality, Cloud...

Your Role Responsibilities? Here's What You'll Do

• Work with customers' technical team to address their design-related questions and suggest the best practices on Informatica Master Data Management product and IDMC platform

• Review customer's implementation architecture and use cases

• Lead the swift resolution of high-priority technical issues that significantly impact customer satisfaction and business operations.

• Guide clients in adopting best practices to integrate and optimize Informatica solutions effectively.

• Work closely with product management, R&D, and cross-product teams to triage customer bugs, prioritize concerns, and enhance product offerings aligned with customer needs.

• Plan proactive customer engagements and work on deflecting situations before they become escalated.

• Anticipate potential issues and engage customers proactively to deflect escalations and strengthen relationships.

• Oversee the creation and maintenance of comprehensive documentation, knowledge bases, and technical webinars to empower support teams and customers.

• Acts as a technical lead for a GCS team and ensure support teams have the technical expertise to handle complex issues effectively, mentoring engineers and setting technical standards.

• Collaborate with management to refine processes affecting both customer interactions and internal support efficiency.

• Utilize Gen AI and other advanced technologies to provide consistent, high-quality support and enhance customer satisfaction.

What We'd Like to See

Expert level knowledge on Informatica Master Data Management product suite required
Experience in a Pre-sales or Post-sales consulting role, preferably in Enterprise software solutions (MDM, Data Integration, Data Quality, Cloud and Databases), ideally using Informatica products.
Proven technical knowledge of deployment of both Cloud and on-premise software solutions and architectures (Data Warehousing, Data Integration, Data Virtualization, Business Intelligence, Application Integration and Microservices)
Track record of successful managing customers and complex data management needs
Deep technical expertise in software architecture, system design, and cloud platforms (AWS, Azure, GCP).
Strong problem-solving and root cause analysis abilities to resolve complex, multi-system issues.
Excellent communication skills to translate complex technical concepts clearly to customers and internal teams.
Customer-focused collaboration experience, working cross-functionally and mentoring technical staff.
Understanding of networking, operating systems and security best practices.
Experience with Informatica IICS platform would be preferable

Role Essentials

Bachelor of computer science or equivalent educational background is preferred.
Minimum 15+ years of relevant professional experience.

Perks & Benefits

Comprehensive health, vision, and wellness benefits (Paid parental leave, adoption benefits, life insurance, disability insurance and 401k plan or international pension/retirement plans
Flexible time-off policy and hybrid working practices
Equity opportunities and an employee stock purchase program (ESPP)
Comprehensive Mental Health and Employee Assistance Program (EAP) benefit

משרות נוספות שיכולות לעניין אותך

MDB

MongoDB Enterprise Architect United States, New York, New York

שיתוף

Collaborate with MongoDB AMP presales team and customer stakeholders to assess legacy applications, their architecture, and dependencies. Design target-state microservice architectures on MongoDB that meet customer business, technical, and operational...

Roles Responsibilities

Collaborate with MongoDB AMP presales team and customer stakeholders to assess legacy applications, their architecture, and dependencies
Design target-state microservice architectures on MongoDB that meet customer business, technical, and operational requirements
Develop modernization roadmaps using the strangler pattern to progressively replace legacy components with modern MongoDB-based services
Define and document data synchronization strategies for hybrid (part legacy / part modernized) deployment states
Architect solutions for integration and data consistency across the broader enterprise application landscape
Facilitate technical workshops and discovery sessions with customer architects, developers, and business leaders
Produce presales deliverables including initial solution architectures, modernization proposals, and presentations to communicate design merits
Produce post-sales detailed technical designs and guide MongoDB services teams and customer teams during implementation
Provide architectural governance and direction throughout modernization projects to ensure quality, scalability, and best practices

Required Qualifications

8+ years of experience in solution architecture, enterprise architecture, or modernization-focused technical leadership roles
Proven track record of designing and delivering modern, cloud-native, microservices-based architectures
Hands-on experience with application modernization strategies, including the strangler fig pattern, domain-driven design, and event-driven architectures
Demonstrated experience with data architecture, including migration, synchronization, and integration patterns for heterogeneous systems
Familiarity with at least one of the legacy technology ecosystems being modernized:

RDBMS-centric applications (PL/SQL, T-SQL)
Monolithic Java or .NET applications

Strong customer-facing skills: ability to facilitate workshops, present designs, and influence technical decision-making
Experience working across both presales (solutioning, proposals) and delivery (detailed design, governance)
Excellent communication, presentation, and documentation skills
Willingness to travel as needed for customer engagement (approximately 25% travel)

$259,000 USD

משרות נוספות שיכולות לעניין אותך

Boston Scientific HR Project Manager Workforce Strategy & Transformation United States, Massachusetts, Marlborough

שיתוף

Lead a portfolio of HR transformation and organizational strategy initiatives within the Global HR PMO. Partner with HR, Finance, IT, Operations, and business leaders to prioritize projects based on strategic...

Strategic portfolio leadership

Lead a portfolio of HR transformation and organizational strategy initiatives within the Global HR PMO
Partner with HR, Finance, IT, Operations, and business leaders to prioritize projects based on strategic value and workforce impact
Ensure alignment of project outcomes with enterprise workforce strategies and long-term business objectives

Enterprise workforce planning execution

Lead the implementation of scalable workforce planning solutions using enterprise technology platforms
Design and operationalize models for headcount, contingent labor, cost analysis, and forecasting
Collaborate with internal stakeholders and external vendors to ensure data accuracy, integration, and governance

Project management & methodology

Apply agile and traditional project management practices to deliver medium to complex projects on time and within scope
Create and manage detailed project plans, timelines, budgets, and resourcing using tools like Microsoft Project
Drive continuous improvement through retrospectives and team performance optimization

Communication & stakeholder engagement

Develop compelling visual dashboards and reporting tools that drive transparency and engagement
Deliver timely project updates and executive-level communications to sponsors and steering committees
Build alignment across global teams and resolve issues through collaborative, solutions-oriented approaches

Required qualifications:

Bachelor’s degree in Human Resources, Business, or a related field
Minimum of 5 years' experience leading strategic HR or workforce planning initiatives
Strong knowledge of enterprise workforce planning tools and platforms
Proven experience in headcount and labor cost modeling, including integration with financial systems
Excellent communication, stakeholder engagement, and change management capabilities
Demonstrated agility and ability to navigate complex global environments
Experience with business process improvement, UX design, or planning optimization

Preferred qualifications:

SCRUM Master, Agile, or Lean certification
Experience with SAP SuccessFactors, Oracle Fusion HCM, or similar HRIS platforms
Background in talent planning, talent acquisition, retention strategies, or employee experience design

Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions:It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

משרות נוספות שיכולות לעניין אותך

Informatica Senior Solutions Architect - United States

שיתוף

As a Senior Solutions Architect, you will provide architecture and design, use case development, feature mapping, consulting, and solution implementation advice for our customers while working with Customer Success Managers,...

Senior Solutions Architect (Austin - Hybrid remote/in-office)

This is a Remote individual contributor role based in the United States, reporting to a Manager, Customer Success Architects. You will work on complex technical challenges where analysis of situations or data requires in-depth evaluation of multiple variables and factors.

Working with the Customer Success Manager, you will engage with customers immediately after the point of sale to: • Understand customer goals and desired outcomes • Develop and map architectural blueprints aligned with customer success metrics • Provide post-sales technical expertise • Ensure customer requirements are met and solutions are functioning according to specifications

Technology You'll Use

Informatica Intelligent Data Management Cloud (IDMC): Cloud Integration Services: - Cloud Data Integration (CDI) ∙ Batch processing ∙ Real-time integration ∙ Change Data Capture (CDC) - Cloud Application Integration (CAI) - Cloud Data Ingestion and Replication (CDIR) - Cloud Data Quality (CDQ) • Platform Capabilities: - AI-powered CLAIRE® engine - Cloud-native architecture - Multi-cloud support - Elastic processing - Serverless computing

Development & Operating Systems: • Programming Languages: - Python - Core Java • Operating Systems: - Linux - Windows

Your Role Responsibilities? Here's What You'll Do

As a Senior Solutions Architect, you will provide architecture and design, use case development, feature mapping, consulting, and solution implementation advice for our customers while working with Customer Success Managers, Professional Services, and Product/Engineering teams.
As a Senior Solutions Architect, you will need to be, patient, and passionate about guiding customers through our products and solutions. You must demonstrate ability to collaborate across departments and communicate with both technical and business audiences.
You will show a commitment to learning new technology trends within Informatica and across other enterprise products.

What We'd Like to See

Lead architecture design, use case development, and solution implementation projects for enterprise customers • Partner with Professional Services teams to ensure seamless handoff for broader service engagements • Collaborate with Product/Engineering teams to align solution designs with best practices and provide valuable product feedback
Be an trusted technical advisor to customers and coach to co-workers throughout the post-sales product implementation phase
Promote customer success through product adoption, usage, expansion, and renewal protection plans
Provide prompt, detailed technical guidance on product features and capabilities
Mentor and support colleagues in the Customer Success team
Create compelling solution presentations and technical proposals
Develop expertise content including: - Whitepapers - Technical documentation - Case studies - Architectural blueprints - Blog posts - Articles for technical/industry publications

Role Essentials

Minimum 7+ years of overall professional experience
5+ years of hands-on experience with Informatica products in the Cloud Data Integration journey, including: - Cloud Data Integration (CDI) - Cloud Application Integration (CAI) - Cloud Data Ingestion and Replication (formerly Cloud Mass Ingestion) - Cloud Data Quality (CDQ)
Experience with major cloud platforms (AWS, Azure, or GCP)
Demonstrated expertise in integrating enterprise applications, including: - SAP - Salesforce - Snowflake - Databricks - Oracle - Kafka - Tableau
Background in architecting solutions for: - Data transformation - Migration strategies - Integration frameworks - High availability systems - Disaster recovery planning
Customer-facing skills with an ability to translate complex technical concepts to multiple audience

Education:

Bachelor's degree in Engineering, Computer Science, or a related field

Perks & Benefits

Comprehensive health, vision, and wellness benefits (Paid parental leave, adoption benefits, life insurance, disability insurance and 401k plan or international pension/retirement plans
Flexible time-off policy and hybrid working practices
Equity opportunities and an employee stock purchase program (ESPP)
Comprehensive Mental Health and Employee Assistance Program (EAP) benefit

משרות נוספות שיכולות לעניין אותך

MDB

MongoDB Senior Pre-Sales Solutions Architect United States, New York, New York

שיתוף

Ideally 8 to 11 years of related experience in a customer facing role, with 5 to 7 years of experience in pre-sales with enterprise software. Minimum of 3 years experience...

As an ideal candidate, you will have:

Ideally 8 to 11 years of related experience in a customer facing role, with 5 to 7 years of experience in pre-sales with enterprise software
Minimum of 3 years experience with modern scripting languages (e.g. Python, Node.js, SQL) and/or popular programming languages (e.g. C/C++, Java, C#) in a professional capacity
Experience designing with scalable and highly available distributed systems in the cloud and on-prem
Demonstrated ability to work with customers to review complex architecture of existing applications, providing guidance on how to improve by leveraging technology
Excellent presentation, communication, and interpersonal skills, with the ability to convey complex technical and business concepts in a clear and compelling manner to technology and business leadership
Ability to strategize with sales teams and provide recommendations on how to drive a multi-threaded account strategy, aligning other MongoDB and ecosystem resources to move towards a mutually beneficial account plan
The ability to travel up to 25%
A Bachelor’s degree or equivalent work experience

You may also have:

Experience selling databases and/or deploying applications with any of the major cloud providers
Experience with database programming and data models
Experience in data engineering or AI/ML projects
Experience in transforming legacy systems and platforms into modern, scalable, and efficient technology stacks
Understanding of popular sales methodologies/ frameworks such as MEDDPICC/ Command of the Message
A MongoDB Certification
A Cloud Provider Certification

In this role, you will work on complex opportunities where analysis of situations or data requires an in-depth evaluation of various factors. You will:

Design and Architect: Design scalable and performant applications, systems and infrastructure for large software projects leveraging MongoDB
Customer Advising and Value Articulation: Guide customers on architecture patterns and optimisation strategies for MongoDB, while clearly communicating its business value to the relevant stakeholders
Sales Partnership: Collaborate with the sales team to drive account success through account planning, opportunity prioritization/qualification and pipeline generation strategy, while taking ownership of the technical aspects (including but not limited to technical discovery, demos, proof of value, presentations, sizing and documentation)
Demand Generation: Proactively generate demand within the sales territory through self-driven technical initiatives, participation in events such as industry trade shows and account-based marketing events
Customer Success: Foster strong customer relationships, build champions and ensure customer success and satisfaction
Innovation and Improvement: Continuously seek opportunities to innovate and improve MongoDB solutions and processes (e.g. by relaying field feedback to the product team), as well as proactively mentor other Solutions Consulting team members
Personal Training and Development: Engage in ongoing training and professional development to stay abreast of MongoDB product suite as well as industry trends

MongoDB Product Suite Mastery:

Core Database Server: Master the fundamentals and advanced features of MongoDB's core database
Atlas and Advanced Services: Gain expertise in Atlas (fully managed cloud database service), Atlas Stream Processing, Atlas Data Lake, Atlas Full-Text Search, Atlas Vector Search, and Charts
Relational Migrator: Learn to migrate from relational databases seamlessly

Market-Relevant Technologies:

Hyperscaler Ecosystem: Gain expertise in designing complex systems utilizing cloud services on hyperscaler platforms
Complementary Technologies: Enhance your skills with partner and complementary technologies such as Apache Kafka and Kubernetes

Modern Architecture Design:

Design Patterns and Methodologies: Embrace best practices in microservices, DevOps, cloud, and security
Cutting Edge RAG and AI Architectures: Help customers on their generative AI journeys and working with industry leading partners in the space

Sales Techniques and Soft Skills:

Effective Communication: Master presentations, demonstrations, and whiteboarding
Client Interaction: Develop strategies for discovery and objection handling

Industry Insights:

Diverse Market Verticals: Gain exposure to a broad spectrum of interesting use cases across various industries

$204,000 USD

West PharmaQuality Project Manager

משרות נוספות שיכולות לעניין אותך

1 2 3 4 5 6

United States, Pennsylvania, West Whiteland Township

68280113

Today

שיתוף

תיאור:

Job Summary

Essential Duties and Responsibilities

Lead the initiative to standardize quality systems between multiple sites. Identify best practices and ensure roll out to relevant sites.
Organize and generate detailed quality information reports to show trends and the impact of process improvements.
Create repeatable methods to assess, measure and communicate the overall quality of a project and deliver key metrics to assess the overall improvement.
Establish and lead cross functional quality related meetings to review and discuss performance, status and prompting necessary actions as required.
Manage goals and metrics for Quality teams/initiatives to adequately monitor the overall effectiveness of the teams/initiatives.
Work with project managers, engineering team, and platform management to develop plans to implement improvement projects.
Ensures teams work closely with product development, supplier/contractors, design, quality, regulatory teams in order to establish standardized KPIs.
Work within Quality or across West Divisions to triage Customer Operational difficulties, define root cause(s), and coordinate the implementation of corrective and preventive actions to preclude recurrence related to quality improvements and quality maturity.
Manage or contribute to both corporate and facility driven initiatives intended to meet defined objectives.
Support front room and or backroom responsibilities during external audits. Including post audit activities, if required.
Responsible for assembling a project team, assigning individual responsibilities, identifying appropriate resources needed, and developing schedules to ensure timely completion of project.
Record detailed customer requirements, constraints, and assumptions with stakeholders in order to establish the project deliverables.
Responsible for project budget estimation, monitoring, and attainment throughout the project lifecycle.
Ensure a common understanding by setting expectations in accordance with the project plan in order to align the stakeholders and team members.
Lead the identification, assessment, monitoring, and closure of project risks throughout the project lifecycle.
Manage changes to the project scope, project schedule, and project costs using appropriate verification techniques in order to keep the project plan accurate, updated, and reflective of authorized changes to facilitate customer acceptance.
Responsible to improve team performance by building team cohesiveness, leading and motivating in order to facilitate cooperation, ensure project efficiency, and boost morale.
Measure project performance using appropriate tools and techniques in order to monitor the progress of the project, identify and quantify any variances, perform any required corrective actions, and communicate to all stakeholders.
May coordinate the activities of one or more exempt and/or non-exempt employees.
All other duties as required.

Education

Bachelor's Degree in Science, Engineering or related field

Work Experience

8+ years of relevant work experience required

Preferred Knowledge, Skills and Abilities

5+ years’ experience in pharmaceutical or medical device environment.
2+ years’ experience in a Quality role.
ASQ CQE certification desirable.
Deep knowledge of quality processes such as CAPA, complaint management, risk management, root cause analysis, statistical sampling plans, FMEA/Fault Tree Analysis, Design Optimization using DOE, Hardware Reliability, Software Reliability, and Design Controls including Design Verification/Validation.
Knowledge of ISO 9001:2008, ISO 13485, 21 CFR 820, 21 CFR 210 & 211, cGMP, cGLP.
Ability to manage direct report(s), work independently and in a team environment.
Demonstrate innovativeness in tactical matters relating to proposing alternate solutions for process improvement.
Experience in FDA regulated environment, pertinent to ISO 13485 is preferred.
Experience with SAP is preferred.
Support and contribute to Lean Sigma programs and activities towards delivery of the set target.
Able to comply with the company’s safety policy at all times.
Able to comply with the company’s quality policy at all times.

Physical Requirements