POSITION SUMMARY

The Quality Systems Manager is a hands-on quality professional with 3–5 years of experience in a regulated industry. This role works closely with the Director of Quality and Regulatory Affairs to actively maintain and improve the Quality Management System (QMS) through daily execution of quality system activities in a medical device manufacturing environment. The position requires direct involvement in quality processes to ensure compliance with FDA, ISO 13485, MDSAP, EU MDR, and other applicable regulatory requirements.

PRIMARY RESPONSIBILITIES

· Own and execute the Nonconforming Product (NCR) process, including product quarantine, documentation, vendor and supplier communication, product returns and rework, root cause investigations, and issue resolution in collaboration with the QA Engineer.

o Serve as the Quality representative on the Material Review Board (MRB) and provide direct support for manufacturing quality issues.

o Actively manage quarantine inventory and prepare routine reports on return status and part performance.

· Prepare, manage, and document Quality Assurance metrics and performance tracking meetings.

o Collect, analyze, and trend quality data such as in-process component performance, final test failures, and other key quality indicators.

· Execute employee training activities and maintain training records, ensuring employees are trained to current procedures and quality system requirements.

· Actively participate in the Corrective and Preventive Action (CAPA) process, including initiating CAPAs, scheduling meetings, documenting actions, and ensuring timely completion of assigned tasks.

· Participate directly in internal and external audits, including preparation, execution, and follow-up activities.

o Perform hands-on internal documentation audits to verify compliance with established procedures and regulatory requirements.

· Draft, revise, and maintain quality documentation to support regulatory compliance, process changes, and manufacturing updates. Documentation may include Nonconformance Reports, Risk Assessments, ECRs/ECOs, QMS procedures and forms, and other related records.

· Perform additional duties and responsibilities as needed to support daily quality operations, regulatory compliance, and evolving business needs.

KNOWLEDGE AND SKILL REQUIREMENTS

· Strong oral and written communication skills.

· Excellent organizational skills with a high level of attention to detail.

· Hands-on, investigative mindset with demonstrated root cause analysis skills.

· Proficiency in Microsoft Office Suite and basic data analysis tools.

· Solid understanding of quality control procedures and applicable regulatory standards.

· Working knowledge of ISO 13485, FDA 21 CFR 820, and/or ISO 9001 preferred.

· Experience with MDSAP, MDR, MDD, and EU Technical File documentation is a plus.

· Technical writing experience is a plus.

Job Type & Location

This is a Permanent position based out of Middlebury, CT.

Pay and Benefits

The pay range for this position is $90000.00 - $125000.00/yr.

Key benefits reported by employees include health and dental insurance, 403(b) retirement matching, tuition reimbursement, and paid holidays. Insurance: Medical and dental insurance options are available.Retirement: The company offers 403(b) matching.Time Off: Benefits include paid holidays and approximately 6 days of PTO per year.Work Culture: Employees often cite a supportive environment with flexibility in time and location.Career Growth: Opportunities for professional development, such as tuition reimbursement, are offered.

Workplace Type

This is a fully onsite position in Middlebury,CT.

Application Deadline

This position is anticipated to close on Feb 26, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.