Quality Assurance Manager at ACE Partners in Lowell, Massachusetts

Job Description:

Quality Manager

Medical Device

Onsite

You will be leading the Quality team, ensuring compliance with Quality Management Systems and supporting engineering efforts in manufacturing and product development.

Key Responsibilities:

• Quality System Oversight: Manage and maintain compliance with internal Quality Management Systems and regulatory standards.
• Regulatory Compliance: Ensure organizational awareness of regulatory requirements and quality standards.
• Management & Reporting: Lead management reviews, report on Quality System performance, analyse metrics, and drive improvements.
• Quality Control: Supervise inspection activities, manage complaint analysis, and corrective/preventive actions.
• Leadership: Guide Quality staff and cross-functional teams throughout product development.
• Risk Management: Support risk assessments, process validations, and design changes.
• Audits & Certifications: Oversee external audits, regulatory certifications, and document control.
• Continuous Improvement: Lead initiatives to enhance Quality Management Systems and enforce cGMP standards.

Must Have:

• Bachelor's degree in Science or Engineering with 7+ years in a regulated medical device environment.
• Knowledge of ISO 13485, FDA 21 CFR 820, EU MDR, CAPA, and customer complaints.
• Experience with Class II/III medical devices and manufacturing process tools (FMEA, Risk Management, Process Validation).

Preferred:

• Quality certifications (ASQ, Lead Auditor).
• Strong leadership, audit management, and data-driven decision-making abilities.

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