Quality Manager

General Information

Position Title:

Quality Manager – Medical Device / Combination Product
Department:
Quality

Reports to:

VP of Quality

Lead and manage quality assurance processes in the development and manufacturing of combination products (drug-device), ensuring operational effectiveness, regulatory compliance, and robust application of design control and engineering fundamentals. The Quality Manager serves as the key quality lead in cross‑functional teams, collaborating with engineering, production, clinical and regulatory partners. The ideal candidate will have working knowledge in the design control requirements for medical device and hands‑on experience in product life cycle, from feasibility prototype through product commercialization.

The candidate will provide quality and compliance input to the project team for project decisions and deliverables (e.g., Product Specifications, Test Methods, Design Reviews, Design V&V, Usability Testing, SW Validation, Process Validation). The candidate shall have the capacity to prioritize project activities and work within a multidisciplinary team.

• Mentor, develop, and supervise a multidisciplinary quality team, including quality engineers, specialists, and inspectors.
• Set clear objectives and performance expectations, provide regular feedback, and drive a culture of accountability, empowerment, and continuous learning.
• Oversee calibration and preventive maintenance program.
• Lead by example, inspiring commitment to quality across the organization.

• Serve as the quality lead for multidisciplinary teams (R&D, regulatory, manufacturing, engineering, supply chain), ensuring quality requirements are integrated at every product stage.
• Facilitate effective communication and alignment, resolve conflicts proactively, and drive collaborative problem‑solving.
• Support and influence cross‑functional projects, including but not limited to design control design and product transfer.

• Provide quality assurance oversight and ensure compliance in the support of combination device development life cycles.
• Ensure product development projects and changes to existing products are conducted in compliance with the Quality System Regulations.
• Oversee compliance for combination device development life cycles according to FDA regulations (21 CFR part 4 & 820), ISO 13485, EU MDR, and other regulatory body regulations and guidelines.
• Provide QA oversight for development projects and changes to existing products.
• Support internal and external audits, CAPA and NCMRs.

• Apply knowledge of design control principles and quality engineering to positively influence new product development efforts, including establishing, reviewing, and approving design inputs/outputs, design verification & validation, process characterization & validation, component qualification.
• Responsible for assuring design projects meet quality goals, and regulatory requirements including FDA regulations (21 CFR part 4 & 820), ISO 13485, EU MDR requirements, and ISO 14971.
• Work with R&D in the creation of requirements for new products and engineering specifications.
• Evaluate product changes for qualification and validation requirements and assist in change implementations.

• Serve as a technical resource for assessing validation requirements, solving test related problems, and developing preventive strategies.
• Lead risk management activities and participate in cross‑functional teams to develop and maintain product risk management files (Risk Management Plan & Report, HA, UFMEA, DFMEA, PFMEA, etc.).
• Lead test method validation activities and Gage R&R studies for Combination Product.
• Assist in the development and approval of design development plans, verification and validation protocols, reports, master V&V plans and reports.
• Assist in development, review and approval of process and equipment validation/qualifications (IQ, OQ, PQ).

• A minimum of 8 years quality assurance/engineering in a regulated industry…