Quality Manager

Additional Location(s):  N/A

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.           

About the role:

The Manager, Quality Assurance – Sterilization & Product Release provides strategic leadership and operational oversight for the site's Quality Assurance and Sterilization Release activities. This individual ensures alignment with Boston Scientific’s Quality policies, regulatory requirements, and business goals, while championing a culture of compliance, collaboration, and continuous improvement. As a key member of the site leadership team, this role supports the daily operations of the site and drives initiatives that ensure product quality and regulatory compliance across operations.

Work model, sponsorship, relocation:

At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.

Your responsibilities will include:

• Provide leadership and strategic direction for the site's Quality Assurance and Sterilization Release functions, ensuring compliance with Boston Scientific, customer, and regulatory standards.

• Oversee day-to-day operations of the Quality team, including engineers, technicians, and support staff, ensuring effective support of site and corporate goals.

• Support sterilization operations by consulting on quality and sterilization issues, problem-solving, and driving proactive risk mitigation strategies.

• Lead staff management activities including recruitment, workforce planning, skills assessment, workload distribution, performance management, training, and professional development.

• Mentor and coach team members in Lean, Six Sigma, and mistake-proofing methodologies to build operational excellence and technical depth.

• Design, implement, and improve inspection, testing, and validation processes to ensure compliance and process control.

• Conduct statistical analyses and cost-of-quality assessments to drive continuous improvement and address nonconformance trends.

• Lead the development, implementation, and improvement of quality systems, CAPA processes, and process controls across production and lab environments.

• Drive continuous improvement initiatives such as Value Improvement Projects (VIP) and Lean Business Practices (LBP) to increase efficiency and reduce waste.

• Facilitate global product sterility release through ongoing quality assurance activities and direct collaboration with Global Sterility Assurance.

• Serve as a cross-functional quality leader, promoting best practices and partnering with internal stakeholders, suppliers, and vendors to ensure product quality.

• Ensure site compliance with applicable FDA, ISO 13485, ISO 11135, and other relevant global regulations and standards.

• Support the development and evolution of the Quality function’s long-term goals, structure, and performance metrics.

• Perform other related duties as required.

Qualifications:

Required qualifications:

• Minimum of 7 years' experience in Quality Assurance, Quality Systems, or Manufacturing in the medical device, pharmaceutical, or other regulated industry

• Minimum of 3 years' experience managing or leading technical or quality teams

• Strong knowledge of FDA regulations, ISO 13485, and ISO 11135

• Demonstrated experience with CAPA systems, validation, risk management, and process controls

• Proven leadership and coaching capabilities across technical and non-technical staff

• Experience collaborating across departments and global teams to achieve business objectives

• Excellent analytical, communication, and problem-solving skills

Preferred qualifications:

• Bachelor's or advanced degree in Engineering, Life Sciences, or a related technical field

• Experience with sterility assurance, sterilization validation, or microbiology-based quality systems

• Lean, Six Sigma, or other continuous improvement certifications

• Experience supporting global manufacturing or sterilization operations

• Familiarity with product release and reverse logistics (returns, clinical, recall, stock management) in a regulated industry

Requisition ID: 617585 

Minimum Salary: $ 103700 

Maximum Salary: $ 197000 

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com—will vary based on actual location of the position and other pertinent 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.

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. 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. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

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!

At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. 

Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered 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.

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.