Boston Scientific Gruppe
Diversity - Innovation - Caring - Global Collaboration - Winning Spirit- High Performance
About the role The Manager, Quality will lead the Quality Engineering and Incoming Quality Control (QC) team responsible for medical product design and manufacturing at Bolt Medical. This leadership role ensures compliance with Boston Scientific's Quality Management System (QMS) and all applicable regulatory requirements, including but not limited to 21 CFR 820, EN ISO 13485:2016, EN ISO 14971:2019, and related standards. This position requires a proactive and strategic quality leader who will drive system excellence, continuous improvement, and team development while supporting the company’s mission to deliver safe and effective medical devices.
Boston Scientific values collaboration and synergy. This role follows an onsite work model requiring employees to be in our local office five days per week. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Relocation assistance is not available for this position at this time.
Your responsibilities will include
Lead the development and implementation of quality policies and procedures that ensure compliance with applicable U.S. and international regulatory standards.
Manage Quality Control functions related to disposable product operations, including receiving inspection, in-process inspection, final inspection, product release, NCR management, clean room monitoring, and supplier quality.
Oversee metrology and calibration activities.
Champion initiatives related to quality reporting systems and continuous improvement efforts.
Identify opportunities for risk reduction and cost improvement while maintaining quality excellence.
Provide leadership, coaching, mentoring, and development for Quality team members and cross-functional stakeholders.
Serve as a site advocate for Quality Best Practices and current Good Manufacturing Practices (cGMP).
Collaborate with engineering teams to develop and maintain Risk Management documentation, including FMEAs and hazard analyses.
Build and scale the Quality Engineering function for disposable devices in alignment with BSCs growth strategy.
Contribute to audits and regulatory inspections, providing expert guidance on quality systems.
Set operational objectives, delegate assignments, and ensure timely completion of work by team members.
Directly manage departmental activities, including performance, staffing, and budget.
Ensure full compliance with quality system procedures and regulatory requirements.
Foster a culture of collaboration, accountability, positivity, and continuous improvement.
Demonstrate professionalism in all interactions with internal stakeholders and external partners.
Qualifications Required qualifications
Bachelor's or Master's degree or equivalent combination of education and experience.
Minimum of 15 years' experience in the medical device industry.
Minimum of 5 years' experience in quality management.
Experience working in Quality within catheter design and production or a similar medical device environment.
Demonstrated experience with Design Controls, Risk Analysis, Process and Product Validation, and statistical methods.
Applied understanding of 21 CFR 820, EN ISO 13485:2016, and ISO 14971:2019.
Expertise in product sterilization, biocompatibility, and clean room compliance.
Proven ability to lead through influence, manage sensitive situations, and interact effectively with executive stakeholders.
Preferred qualifications
Strong verbal and written communication skills with an ability to generate clear, concise, and timely reports.
Ability to manage significant workloads, prioritize effectively, and deliver results under pressure.
High attention to detail, accuracy, and proactive problem-solving skills.
Strong interpersonal and listening skills, with the ability to adapt to change and build positive working relationships.
Demonstrated success in creating realistic plans, setting goals, and executing cross-functional initiatives efficiently.
Requisition ID: 618964
Minimum Salary: $103,700
Maximum Salary: $197,000
Compensation will vary based on actual location of the position and other factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.
Compensation for non-exempt (hourly), non-sales roles may 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 for exempt, non-sales roles may 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.
Boston Scientific is committed to solving the challenges that matter most. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. We stand for inclusion, equality, and opportunity for all.
Boston Scientific Corporation is an equal opportunity employer. The Company takes steps to ensure recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made without regard to protected classes.
Please be advised that certain U.S. based positions require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role requires proof of vaccination as a condition of employment.
All safety-sensitive positions require prohibited substance testing.
Nearest Major Market:
San Diego
Job Segment:
Compliance, Medical Device, QC, Quality Engineer, Legal, Healthcare, Quality, Engineering
#J-18808-Ljbffr
About the role The Manager, Quality will lead the Quality Engineering and Incoming Quality Control (QC) team responsible for medical product design and manufacturing at Bolt Medical. This leadership role ensures compliance with Boston Scientific's Quality Management System (QMS) and all applicable regulatory requirements, including but not limited to 21 CFR 820, EN ISO 13485:2016, EN ISO 14971:2019, and related standards. This position requires a proactive and strategic quality leader who will drive system excellence, continuous improvement, and team development while supporting the company’s mission to deliver safe and effective medical devices.
Boston Scientific values collaboration and synergy. This role follows an onsite work model requiring employees to be in our local office five days per week. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Relocation assistance is not available for this position at this time.
Your responsibilities will include
Lead the development and implementation of quality policies and procedures that ensure compliance with applicable U.S. and international regulatory standards.
Manage Quality Control functions related to disposable product operations, including receiving inspection, in-process inspection, final inspection, product release, NCR management, clean room monitoring, and supplier quality.
Oversee metrology and calibration activities.
Champion initiatives related to quality reporting systems and continuous improvement efforts.
Identify opportunities for risk reduction and cost improvement while maintaining quality excellence.
Provide leadership, coaching, mentoring, and development for Quality team members and cross-functional stakeholders.
Serve as a site advocate for Quality Best Practices and current Good Manufacturing Practices (cGMP).
Collaborate with engineering teams to develop and maintain Risk Management documentation, including FMEAs and hazard analyses.
Build and scale the Quality Engineering function for disposable devices in alignment with BSCs growth strategy.
Contribute to audits and regulatory inspections, providing expert guidance on quality systems.
Set operational objectives, delegate assignments, and ensure timely completion of work by team members.
Directly manage departmental activities, including performance, staffing, and budget.
Ensure full compliance with quality system procedures and regulatory requirements.
Foster a culture of collaboration, accountability, positivity, and continuous improvement.
Demonstrate professionalism in all interactions with internal stakeholders and external partners.
Qualifications Required qualifications
Bachelor's or Master's degree or equivalent combination of education and experience.
Minimum of 15 years' experience in the medical device industry.
Minimum of 5 years' experience in quality management.
Experience working in Quality within catheter design and production or a similar medical device environment.
Demonstrated experience with Design Controls, Risk Analysis, Process and Product Validation, and statistical methods.
Applied understanding of 21 CFR 820, EN ISO 13485:2016, and ISO 14971:2019.
Expertise in product sterilization, biocompatibility, and clean room compliance.
Proven ability to lead through influence, manage sensitive situations, and interact effectively with executive stakeholders.
Preferred qualifications
Strong verbal and written communication skills with an ability to generate clear, concise, and timely reports.
Ability to manage significant workloads, prioritize effectively, and deliver results under pressure.
High attention to detail, accuracy, and proactive problem-solving skills.
Strong interpersonal and listening skills, with the ability to adapt to change and build positive working relationships.
Demonstrated success in creating realistic plans, setting goals, and executing cross-functional initiatives efficiently.
Requisition ID: 618964
Minimum Salary: $103,700
Maximum Salary: $197,000
Compensation will vary based on actual location of the position and other factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.
Compensation for non-exempt (hourly), non-sales roles may 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 for exempt, non-sales roles may 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.
Boston Scientific is committed to solving the challenges that matter most. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. We stand for inclusion, equality, and opportunity for all.
Boston Scientific Corporation is an equal opportunity employer. The Company takes steps to ensure recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made without regard to protected classes.
Please be advised that certain U.S. based positions require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role requires proof of vaccination as a condition of employment.
All safety-sensitive positions require prohibited substance testing.
Nearest Major Market:
San Diego
Job Segment:
Compliance, Medical Device, QC, Quality Engineer, Legal, Healthcare, Quality, Engineering
#J-18808-Ljbffr