Boston Scientific Gruppe
Sr. Quality Systems Engineer- Global Design Activities
Boston Scientific Gruppe, Marlborough, Massachusetts, us, 01752
Overview
Senior Quality Systems Engineer - Global Design Activities (on-site in Marlborough, MA) Recruiter:
Spencer Gregory Hale Responsibilities
Demonstrated competency in implementing effective global design activities procedures to support the development of products to meet or exceed internal and external requirements. Partner with upstream and downstream process owners to ensure proper linkages with the Global Risk Management Process (production and process controls, material controls, post-market support). Act on feedback trends from QS audits, product submissions, and QMR metrics by driving process improvement projects across the Risk Management Sub-Process; analyze qualitative and quantitative data and synthesize large data sets to identify key themes. Influence key stakeholders through collaborative community engagement; connect SMEs across divisions to promote best practices and efficient problem solving. Support internal and external audits and audit responses for existing products. Monitor compliance with company policies and procedures. Global CAPA ownership with demonstrated experience in complex, multi-site / multi-division problem-solving. Contribute as a leader or team member in supporting quality disciplines, decisions, and practices. Apply sound, systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues. Develop and execute streamlined business processes to achieve VIP/Continuous Improvement goals. Qualifications
Bachelor’s degree in Science, Health, or Engineering. Minimum of 5 years of Medical Device design controls and risk management experience. Understanding of US and International regulations including 21 CFR, 820, ISO 13485, Medical Device Directive, EUMDR, EN ISO 14971. Preferred qualifications
Strong communication (oral and written) and presentation skills. Familiar with Microsoft Office Suite (Excel, PPT, Word). Compensation & Benefits
Requisition ID: 617149 Minimum Salary: $86,600 Maximum Salary: $164,500 The anticipated compensation and benefits offered by Boston Scientific (BSC) will vary based on location and other factors. Compensation will be commensurate with experience and credentials. This role is not typically hired at the bottom or top of the salary range. Compensation for non-exempt (hourly), non-sales roles may include variable compensation and annual bonus targets. Compensation for exempt, non-sales roles may include variable compensation, annual bonuses, and long-term incentives, subject to plan eligibility. Compliance
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. Boston Scientific Corporation is an equal opportunity employer. Recruitment, hiring, assignment, promotion, compensation, and other personnel decisions are made without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information, or any other protected class. Among other requirements, Boston Scientific maintains safety-sensitive position testing requirements. This role is safety-sensitive and may be subject to a prohibited substance test to comply with applicable laws. Nearest Major Market:
Boston Job Segment:
Senior Quality Engineer, Medical Device Engineer, Risk Management, Compliance, Systems Engineer, Engineering, Finance, Legal
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Senior Quality Systems Engineer - Global Design Activities (on-site in Marlborough, MA) Recruiter:
Spencer Gregory Hale Responsibilities
Demonstrated competency in implementing effective global design activities procedures to support the development of products to meet or exceed internal and external requirements. Partner with upstream and downstream process owners to ensure proper linkages with the Global Risk Management Process (production and process controls, material controls, post-market support). Act on feedback trends from QS audits, product submissions, and QMR metrics by driving process improvement projects across the Risk Management Sub-Process; analyze qualitative and quantitative data and synthesize large data sets to identify key themes. Influence key stakeholders through collaborative community engagement; connect SMEs across divisions to promote best practices and efficient problem solving. Support internal and external audits and audit responses for existing products. Monitor compliance with company policies and procedures. Global CAPA ownership with demonstrated experience in complex, multi-site / multi-division problem-solving. Contribute as a leader or team member in supporting quality disciplines, decisions, and practices. Apply sound, systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues. Develop and execute streamlined business processes to achieve VIP/Continuous Improvement goals. Qualifications
Bachelor’s degree in Science, Health, or Engineering. Minimum of 5 years of Medical Device design controls and risk management experience. Understanding of US and International regulations including 21 CFR, 820, ISO 13485, Medical Device Directive, EUMDR, EN ISO 14971. Preferred qualifications
Strong communication (oral and written) and presentation skills. Familiar with Microsoft Office Suite (Excel, PPT, Word). Compensation & Benefits
Requisition ID: 617149 Minimum Salary: $86,600 Maximum Salary: $164,500 The anticipated compensation and benefits offered by Boston Scientific (BSC) will vary based on location and other factors. Compensation will be commensurate with experience and credentials. This role is not typically hired at the bottom or top of the salary range. Compensation for non-exempt (hourly), non-sales roles may include variable compensation and annual bonus targets. Compensation for exempt, non-sales roles may include variable compensation, annual bonuses, and long-term incentives, subject to plan eligibility. Compliance
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. Boston Scientific Corporation is an equal opportunity employer. Recruitment, hiring, assignment, promotion, compensation, and other personnel decisions are made without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information, or any other protected class. Among other requirements, Boston Scientific maintains safety-sensitive position testing requirements. This role is safety-sensitive and may be subject to a prohibited substance test to comply with applicable laws. Nearest Major Market:
Boston Job Segment:
Senior Quality Engineer, Medical Device Engineer, Risk Management, Compliance, Systems Engineer, Engineering, Finance, Legal
#J-18808-Ljbffr