Quality Manager (Medical Device Contract Manufacturing)

Cadence Inc•Cranston, RI

13d•Onsite

About The Position

We are seeking an experienced and hands-on Quality Manager to lead the Quality function at our growing medical device contract manufacturing site in Cranston, RI. In this role, you'll have the opportunity to make a meaningful impact within a growing and highly collaborative organization focused on quality, customer partnership, and operational excellence. Your leadership will directly influence site performance, team development, customer satisfaction, and long-term business success, and it will be critical to supporting operational excellence, developing talent, and enabling continued growth at the site.

Requirements

Bachelor's degree in Engineering, Quality, or a related technical discipline preferred.
Five or more years of progressive Quality leadership experience in a regulated manufacturing environment; medical device and/or pharmaceutical manufacturing experience is strongly preferred.
Strong working knowledge of FDA regulations and quality standards, including: ISO 13485, FDA 21 CFR Part 210 and 211, FDA 21 CFR Part 11, Validation and qualification requirements within regulated manufacturing environments
Experience leading quality teams within a manufacturing operation of significant scale and complexity.
Demonstrated success supporting customer audits, FDA inspections, and/or notified body audits.
Strong problem-solving, communication, and cross-functional leadership skills.
Experience with statistical analysis, root cause investigation methodologies, and continuous improvement tools preferred.
Ability to balance strategic leadership with hands-on execution in a fast-paced manufacturing environment.

Responsibilities

Lead, develop, and mentor the site Quality team, including Quality Engineers, Technicians, Metrology personnel, Supervisory staff, and Quality Inspectors.
Ensure compliance with applicable FDA regulations, ISO standards, customer requirements, and internal quality management systems.
Maintain and continuously improve the site's Quality Management System (QMS), including CAPA, nonconformance management, complaint handling, document control, change management, and internal audits.
Provide leadership and oversight for validation activities, including IQ/OQ/PQ, process validation, equipment qualification, and computerized system validation.
Prepare for and support customer audits, regulatory inspections, and third-party audits, including coordinating responses and driving corrective actions to closure.
Partner with Manufacturing and Engineering teams to investigate quality issues, perform root cause analysis, mitigate risks, and implement sustainable improvements.
Monitor and analyze quality metrics to identify trends, address risks, and drive performance improvements.
Ensure inspection and metrology systems are capable, compliant, and effective in supporting manufacturing and customer requirements.
Foster a culture of quality, accountability, continuous improvement, and operational excellence throughout the facility.
Coach and develop team members to strengthen technical expertise, leadership capabilities, and overall organizational effectiveness.