Senior Quality Assurance Manager

Location

Coventry, Rhode Island, United States

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.

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.

• 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.

• 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.

• 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.

Salary range: $131,700 – $250,200
. Compensation is commensurate with level of experience and may include bonuses and long‑term incentives. Core and optional employee benefits are available through Boston Scientific.

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 U.S. 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.

This role is deemed safety‑sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement.