Senior Quality Assurance Manager

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:
Boston Scientific was recognized as a Glassdoor Best Place to Work in 2026, ranking No. 15 on the Top 100 list, reflecting the culture our employees experience every day.

The Senior Quality Assurance Manager provides leadership for site sterilization release activities in Coventry, Rhode Island. This role partners closely with the Quality Systems Manager to develop, implement, coordinate and monitor quality systems that ensure compliance with all regulatory and company requirements. As a key member of the site leadership team, this position drives continuous improvement, supports daily operations and ensures product quality and patient safety across sterilization processes.

Work model, sponsorship, relocation:
This role is on-site in Coventry, Rhode Island. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.

Your responsibilities will include:

* Lead sterilization release activities and ensure compliance with all quality system requirements and regulatory standards.

* Manage the day-to-day operations of the Quality Assurance team, including quality engineers and technicians.

* Maintain and improve quality systems, including process validation, process control, nonconformance management and CAPA systems.

* Support daily site operations and sterility processing, providing expertise in quality and sterilization-related issues.

* Provide guidance, consultation and problem-solving support to address quality and operational challenges.

* Direct workforce planning, hiring, performance management, training compliance and professional development of team members.

* Coach and advise supervisors, group leaders and staff on technical and operational matters.

* Design and implement inspection and testing methods; conduct quality assurance testing and statistical analysis.

* Facilitate global sterility release of products through collaboration with corporate sterility teams.

* Ensure compliance with FDA, ISO 13485, ISO 11135 and all applicable federal, state and international regulations.

* Contribute to quality organization design and support development of long-term quality objectives and strategies.

* Promote a culture of continuous improvement, patient safety and adherence to the Boston Scientific Quality Policy.

* Ensure adequate resources, tools and systems are in place to maintain quality system compliance.

* Perform additional responsibilities as required.

Qualifications:

Required qualifications:

* Bachelor's degree in engineering, life sciences or a related field

* Minimum of 7 years' experience in quality assurance within a regulated industry

* Minimum of 3 years' experience in a leadership or people management role

* Experience with sterilization processes and sterility assurance

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

* Experience with CAPA, nonconformance systems and process validation

* Demonstrated ability to lead teams and drive continuous improvement initiatives

* Strong problem-solving, analytical and decision-making skills

* Excellent communication and stakeholder management skills

Preferred qualifications:

* Advanced degree in engineering, science or a related discipline

* Experience in the medical device industry

* Experience working with global quality or sterilization teams

* Certification in quality (e.g., ASQ CQE, CQM)

* Experience supporting audits and regulatory inspections

Requisition

Minimum Salary:$131700

Maximum Salary: $250200

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) - see  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).

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