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To ensure quality and technical standards are in place and in use ensuring product and service consistently meets customers’ requirements.
Developing and implementing continuous improvement programs covering production processes and quality management systems.
Analysis of quality problems to identify root causes and implement corrective action to reduce risk of quality failure.
The person will have a strong understanding of the requirements of and the implementation of quality management system and technical standards.
• Review and approval of qualification lifecycle documents for facility & utilities, process equipment and laboratory instrumentation.
• Review and approval of laboratory test results
• Ensuring Data Integrity of laboratory results
• Assist in the investigation and closure of Laboratory investigations, Deviations and Out of specifications
• Communication with External Customers
• Maintenance of validation status of QC and production facilities, equipment, instrumentation and software via review and approval of planned changes and new process introduction.
• Review and approve sampling plans & procedures related to manufacture of products.
• Lead and perform risk assessments and implement control plans.
• Review and approve batch records against approved specifications, quality standards, company procedures and regulatory filings for release of product to market.
• Ensure non conformances/deviations/complaints are investigated and assessed for root cause and identification and closure of effective CAPA’s
• Support quality systems implementations and user acceptance testing where required.
• Lead in Continuous Improvement of Quality processes
• Interact and collaborate with Laboratory; Operations and other functions to support Analytical Laboratory Services and production and timely resolution of issues and investigations.
• Participate in internal audit and Shop Floor audit program
• Maintenance of professional and technical knowledge by attending educational events, reviewing publications, establishing networks and benchmarking.
• Act in accordance with the company’s Guiding Principles and adherence to the corporate Code of Conduct.
• Compliance to all local site Environmental, Health and Safety regulations.
• Compliance to all local site company policies, procedures and corporate policies.
• Perform additional duties as required
Desired:
• 5+ years’ previous industrial experience of working as a Quality Engineer or Quality specialist in an ISO13485, EU GMP or 21 CFR Part 210,820 or 211 design or manufacturing environment. Aseptic or sterile manufacturing experience is desired.
• Review and approval of facility, equipment and process validation
• Analytical Method, Equipment/Process and Software Qualification
• Involvement in new product introduction or technical transfer activities.
• Quality planning and communication skills.
• Strong technical writing ability.
• Ability to liaise with customers and suppliers in an informed professional manner.
• Excellent IT, communication and interpersonal skills using current office technologies.
• Ability to work on own initiative, coupled with involvement on cross-functional teams.
• Interest and willingness to learn new skills and take on new tasks
• Strong sense of urgency and flexibility.
• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
• Support and contribute in Lean Sigma programs and activities towards delivery of the set target
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As a Sr. Staff Technical Program Manager, you will partner with key Engineering, Product, Product Design, Marketing, and Analytics stakeholders to conduct data-driven experiments and deliver features for MongoDB. As a seasoned program leader, you will be responsible for one of our most mission-critical programs this fiscal year, and own executive level communication related to the program.
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This role is a cornerstone of our Global VIP Support function, responsible for proactive, high-touch (“white-glove”) technology support for our most senior leaders and their Executive Assistants (EAs).
As the West Coast VIP Support Ambassador, you are the single-threaded owner for executive technology needs in the US Pacific time zone, partnering closely with our NYC (US/Eastern) and Dublin (EMEA) VIP specialists to deliver near 24×5 global coverage.
You will blend senior-level IT support with strong AV and collaboration expertise to protect the most critical executive workflows and events. You will also play a key role in developing and delivering IT training for the EA community, and partnering with Internal Comms and AV on All Hands support. This role requires excellent judgment, calm under pressure, empathy, and the ability to drive complex issues to resolution while maintaining executive trust.
Key Responsibilities1. White-Glove Incident Response & Resolution
2. Proactive Care, Stability, & Event / All Hands Support
3. Executive Relationship Management, EA Training & Travel Support
0–30 Days: Foundational Readiness & Onboarding
30–90 Days: Independent Ownership & Proactive Action
90 Days – 1 Year: Efficiency, Strategy & Process Ownership
Required
Preferred
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In this role you will be responsible for performing Supplier Quality activities associated with external suppliers. This role performs activities to ensure West supplier’s maintain compliance with West’s procedures and policies. You will interface with R&D, Sourcing, Design Quality, Regulatory and Operations Quality to drive improved supplier quality performance.
Establish and successfully executesupplier management planswhich will align to overall business objectives
Maintain a strong collaborativepartnership
supplier performanceincluding incoming failures, manufacturing yields and field failures to drive Supplier Corrective Action Reports (SCARs)
ExecuteSupplier Corrective Action Requests(SCAR) with suppliers, ensuring effective and timely closure
Work with suppliers, R&D, and Sourcing on continuous improvement of supplier performance includingsupplier changerequest.
Evaluate potential new or future suppliers and support supplierselection processwith the cross-functional team
Participate in cross-functional teams of design engineering and quality engineering to work with suppliers duringproduct developmentand ensures agreement for manufacturable, cost-effective designs
Approves components for use in products by drivingProduct Approvalactivities with the suppliers
Supports Supplier evaluation,auditmanagement and related records
Supports the evaluation and development ofQuality Agreements and purchasing specificationswith suppliers
Support the development of anIncoming Inspection strategyon purchased products
Experience working with suppliers and supplier engagement activities
Knowledge of sterilization process is preferred
Knowledge of cGMP, cGDP, relevant ISO standards, medical device requirements and other international regulations
Familiarity with MasterControl, SAP and working knowledge of statistical data analysis
Fluent in English
Thorough understanding of validation activities and risk management principles and techniques
Strong problem-solving and critical thinking skills
Negotiation skills and collaborating with suppliers
Ability to work under high volume production and fast changing environment
Willingness to work in a cross-functional team with different time zones
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