דרושים Senior Quality Assurance Engineer - Field Action Team Lead ב-Boston Scientific ב-ארהב

About the Role:

In this dynamic production environment, they have the opportunities to develop, establish and maintain quality engineering methodologies, systems, and practices. Serving as representatives of the Quality organization, they will improve awareness, visibility and communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities.

Your Responsibilities Include:

• Partners with Manufacturing Engineering and Production core team members for daily manufacturing line support decisions and practices.
• Collaborates with cross-functional team to evaluate manufacturing results, assist defect detection, primary cause identification, and understanding corrective and preventative actions.
• Identifies and implements effective process control systems to support the development, qualification, validation and verification to meet or exceed internal, external, and regulatory requirements.
• Supports a culture of continuous improvement by advancing improvements to existing processes and controls.
• Proactively investigates, identifies, and implements best-in-class Quality Engineering practices.
• Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Broadly engages with production teams across all shifts to develop and support solutions to improve outgoing quality.
• Provide task direction, coaching, and mentorship for technician team members.
• Participate in team decision-making and display team problem-solving/communication skills.

What We’re Looking For:Required Qualifications:

• Bachelor’s degree in engineering, technology, mathematics, or related science
• 2+ years of relevant experience in a regulated industry
• Strong verbal and written communications skills; Good documentation practices
• Works effectively in a Controlled Environment Area (CEA) manufacturing environment
• Self-starter with a proven ability to successfully work with minimal supervision
• Knowledge of basic Quality Management Systems
• Proficient with Microsoft Office tools (Word, Excel, PowerPoint, Outlook)

Preferred Qualifications:

• Medical device experience
• Comfortable with utilizing analytical equipment (including microscopes)
• Strong analytical skills, problem solving, and statistical analysis (Excel, Minitab)
• Experience with the following disciplines: manufacturing/process engineering, post-market complaints, supplier quality, CAPA, risk management
• Experience running/owning nonconforming event risk assessments and investigations
• Proficient using manufacturing control software (various MES, MasterControl, etc.)
• Project management experience

Maximum Salary: $ 132000

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.

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.

Your responsibilities include:

• Perform all aspects of the monthly financial close including generation of monthly and quarterly management reporting and variance/trend analysis
• Supports the annual planning process for the functional areas of responsibility including coordinating with the various functional groups to develop operating expense budgets and providing analytical support to identify key business drivers
• Analysis and submission of functional budgets
• Support decision-making process to enable profitable growth
• Support regular and adhoc reporting and presentations to management
• Identify and drive cost saving opportunities across the SG&A functions
• Quickly respond to numerous ad hoc queries from internal customers (including Senior Management)

Minimum Qualifications:

• Bachelor’s degree in Finance or Accounting
• 5+ years of relevant FP&A experience
• MS Excel and PowerPoint required, financial tools (Hyperion (Oracle), SAP) preferred
• Excellent oral and written communication skills
• Strong financial analysis, communication, organizational and prioritization skills
• Strong attention to detail and data accuracy

Preferred Qualifications:

• Ability to multi-task and set priorities/execute in a high-paced organization
• Ability to work in a dynamic environment, adhere to tight deadlines
• Team orientated
• Must have a process improvement mindset and strong problem-solving skills

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.

About the role:

This position is responsible for the strategic planning and execution of PI Vascular Medical Affairs and Professional Education meetings.

Your responsibilities will include:

• Manage program logistics including sleeping rooms, flights, food and beverage, ground transportation, meeting room set-up, budgets, attendee management, communications, and onsite materials.

• Build and manage event registration processes using Cvent, ensuring accurate data management, providing attendee support, generating reports, and collaborating with cross-functional teams for seamless event execution.
• Manage surveys and evaluate feedback from the training programs and working closely with the Program Mangers to make changes to our current programs to ensure use of both best practice and new innovative education methods.

• Ensures consistency and collaboration for meetings while following established guidelines, processes, and tools.
• Defines, tracks, and maintains budgets while ensuring cost-saving measures and spending are within allocated amounts.
• Maintains and enhances knowledge of the meetings & events industry trends and best-in-class practices.
• Partners with and manages vendors to ensure objectives are being met.
• Runs reports and presents data metrics to leadership for all Medical Affairs & Ed as requested.
• Planning and coordinating other projects that contribute to the accomplishment of the clinical education goals and objectives
• Communicates proactively to stakeholders across all levels of the organization.
• Educates cross-functional teams, provides direction, and establishes solutions where appropriate.
• Ensures all company policies and compliance practices are being followed.

Required qualifications:

• Bachelor’s degree or equivalent
• A minimum of 5 years of related experience in event/meeting planning
• Proven history of working on international HCP programs and outside of the US compliance policies.
• Candidate must have appetite for innovation and continuous learning.
• Ability to develop and maintain relationships with physician customers and sales teams.
• Works independently on complex meetings
• Must be a strong communicator and collaborator
• Ability to develop new processes and adjust practices to meet business needs.

• Strong organizational and multitasking skills with meticulous attention to detail.
• Ability to handle high volume workload and fast pace; manage stress

• Strong project management and organization skills; detail-oriented
• Proficient in the use of Microsoft Office Suite, Cvent and SalesForce.com
• Domestic travel required up to 20%
• Ability to lift 20lbs

• Ability to work extended hours/weekend hours, as needed

Preferred qualifications:

• Experience in the medical device industry

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.

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

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.

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.

Your Responsibilities will Include:

• Produce high quality products, safely, on time for the customer at the lowest cost
• Facilitate and partner with a cross functional production team of production, quality and manufacturing engineering team members to achieve annual safety, quality, service and cost goals while maintaining a high engagement & high-performance culture
• Identify customer requirements to deliver the right products at the right time
• Be responsive & flexible to customer demands
• Achieve & exceed product cost goals
• Support new product development readiness activities for the line team
• Manufacture products to the highest quality standards and ensure compliance to all Boston Scientific policies and regulations
• Promote safety, quality & compliance among the team while maintaining Good Manufacturing Practices
• Foster teamwork and enable a culture of Operational Excellence throughout the entire cross-functional team
• Ensure effective two-way communication between the production line team and cross-functional support teams
• Manage, motivate, develop, and involve product builders through coaching and performance management
• Embed the company values through demonstration & recognition of individual & team behaviors
• Utilize production area planning tools to ensure all resources are in place to achieve team commitments such as Direct Labor Staffing, Equipment Capacity, Support Team, and Space
• Ensure product builder training is effective & efficient and maintain training versatility across entire team
• Utilize leader standard work to ensure lines are meeting standards and escalate appropriately
• Lead & create team engagement around continuous improvement goals for safety, quality, service, cost and space through the utilization of lean and operational excellence tools and best practices
• Benchmark and share best practices
• Partner with materials management team for build planning and material delivery systems and tools
• Analyze build plan requirements and provide forward looking monthly production commitments
• Anticipate requirements and position resources to meet & exceed the customer needs
• Provide appropriate input into the long-term planning of the production area

Required Qualifications:

• Bachelor’s Degree or equivalent combination of education and experience will be considered in lieu of degree
• Manufacturing or engineering experience
• Solid computer skills required including Microsoft Excel, Word, and PowerPoint
• Demonstrated Lean tools/systems experience
• Able to support and lead a production team working 2nd shift hours (1:30 PM – 9:30 PM), Monday through Friday.
  

Preferred Qualifications:

• 3+ years of supervisor/management experience
• Experience in a regulated environment
• Medical device industry experience
• Strong written and verbal communication skills with the ability to communicate at all levels of the organization
• Ability to be flexible and agile
• Ability to be a self-starter

Maximum Salary: $ 132000

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.

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.

Responsibilities:

Assist in process optimization projects for the regulatory affairs area (e.g. database maintenance, regulatory controls, automation).
Perform data analysis and report findings.
Process mapping to identify areas for optimization and automation

Requirements

Desirable skills or interests:

skills to clean and preprocess data to ensure its accuracy and consistency;
Interests in programming languages, scripts for task automation, database management

Your responsibilities will include:

• Identify and fix problems that arise with automated and manual production equipment in a quick and effective manner to minimize downtime
• Perform routine maintenances and document the details in the machine maintenance system in compliance with the Quality System
• Monitor processes and perform adjustments to ensure product quality
• Evaluates and orders necessary equipment, tools and fixtures.
• Revise existing documents, processes, and/or methods to correct or improve processes/product
• Ability to handle the physical demands of the job, including moving equipment, standing for long periods, and handling materials
• Work with vendors/suppliers to procure and install tooling, fixtures, and/or equipment
• Participate in the redesign and/or development of equipment with the Process Development team to enable the integration of new products
• Contribute toward MCT continuous improvement initiatives to enhance performance, reduce downtime, improve overall manufacturing efficiency, and other Value Improvement Projects (VIP)

Required Qualifications:

• 1 year with High School Diploma and/or equivalent experience, training, or apprenticeships

Preferred Qualifications:

• Associate’s Degree in electronics, robotics, or related technical field

Maximum Salary: $ 71552

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.

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.