Senior Quality Assurance Manager

Boston Scientific•Coventry, RI

12h•Onsite

About The Position

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.

Requirements

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

Nice To Haves

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

Responsibilities

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.