Quality Manager
An innovative product development and engineering firm is seeking a Quality Manager to lead its quality function and oversee an established ISO 13485:2016-certified Quality Management System (QMS). This full-time opportunity focuses on supporting the design and development of cutting-edge medical devices for a diverse client base. You'll leverage your expertise in medical device regulations, FDA requirements, ISO standards, design controls, and risk management to ensure products and development processes meet the highest standards of quality and compliance.
This is an exciting opportunity for a quality leader who wants to do more than maintain compliance. You'll have the opportunity to build and lead the quality team, influence engineering and product development processes, and serve as a strategic quality partner to clients and internal stakeholders. Working alongside multidisciplinary engineering and program management teams, you'll have visibility into the entire product development lifecycle, from initial concept through design transfer and manufacturing. If you're passionate about building strong quality systems, developing people, and helping bring transformative medical technologies to market, this is an opportunity to make a meaningful impact.
Required Skills & Experience
- Bachelor's degree in Engineering, Life Sciences, or a related field.
- 7+ years of quality experience within the medical device industry.
- 3+ years of experience working in a medical device design, engineering, or product development environment.
- 2+ years of people management or team leadership experience.
- Hands-on experience maintaining and improving an ISO 13485:2016-certified Quality Management System.
- Strong knowledge of FDA 21 CFR Part 820 (QMSR), ISO 14971:2019, and medical device design controls.
- Experience managing design control activities, including design inputs and outputs, design reviews, verification and validation, design transfer, and Design History Files (DHFs).
- Experience leading internal audits and hosting external audits, including FDA inspections, registrar audits, or notified body audits.
- Strong experience managing CAPA, nonconformances, change control, root-cause analysis, and continuous improvement initiatives.
- Excellent communication, leadership, organizational, and problem-solving skills.
Desired Skills & Experience
- Master's degree in Engineering, Life Sciences, or a related discipline.
- Experience working with EU MDR 2017/745 requirements.
- Familiarity with IEC 62304 (medical device software), IEC 62366-1 (usability engineering), and IEC 60601-1 (electrical safety).
- Experience developing quality agreements and quality plans with medical device clients.
- Knowledge of supplier qualification, supplier audits, and supplier performance management.
- Experience with design transfer, process validation, and equipment qualification, including IQ/OQ/PQ.
- Familiarity with calibration programs, test method validation, document control, and training management.
- ASQ Certified Quality Engineer (CQE), Certified Quality Manager/Organizational Excellence (CQM/OE), or Certified Biomedical Auditor (CBA).
- ISO 13485 Lead Auditor certification.
What You Will Be Doing Tech Breakdown
- ISO 13485:2016 Quality Management Systems
- FDA 21 CFR Part 820 (QMSR)
- ISO 14971:2019 Risk Management
- EU MDR 2017/745
- Medical Device Design Controls
- CAPA, Nonconformance, and Change Control
- Design History Files (DHF)
- IEC 62304, IEC 62366-1, and IEC 60601-1
- Process Validation (IQ/OQ/PQ)
Daily Responsibilities
- Lead and continuously improve the company's ISO 13485:2016-certified Quality Management System.
- Serve as the Management Representative and maintain certification through surveillance and recertification audits.
- Ensure design controls are consistently implemented across medical device development programs.
- Oversee design and development planning, design inputs and outputs, design reviews, verification and validation, and design transfer activities.
- Manage risk management processes and ensure risk management files are integrated throughout product development.
- Lead the internal audit program and serve as the primary quality contact for external audits, FDA inspections, registrar audits, and client supplier audits.
- Establish quality objectives, performance metrics, and management review processes to measure QMS effectiveness.
- Own CAPA, nonconformance, and change control processes while driving root-cause analysis and corrective action implementation.
- Oversee document control, records management, employee training, and supplier quality programs.
- Partner with clients on quality agreements, quality plans, and product transfer to manufacturing partners.
- Oversee calibration, equipment maintenance, test method validation, and process validation activities.
- Hire, develop, mentor, and manage the quality team while driving a culture of accountability and continuous improvement.
- Collaborate with engineering, program management, and clients to ensure quality is integrated throughout the product development lifecycle.
Applicants must be currently authorized to work in the US on a full-time basis now and in the future
