Sr. Manager Design Quality
Position Summary
We are seeking a Senior Design Quality Engineering Manager to provide quality leadership across product development programs and ensure compliance with quality system requirements throughout the design lifecycle. This individual will partner with R&D, Manufacturing, Regulatory, Clinical, and Program Management teams to drive quality excellence from concept through commercialization.
The ideal candidate will bring approximately 10-15 years of experience in medical device quality engineering, design assurance, or product development quality, including experience leading teams and supporting complex product development programs in a regulated environment.
Key Responsibilities
- Lead Design Quality activities across new product development, sustaining engineering, and product lifecycle management initiatives.
- Provide strategic quality leadership during product development efforts from concept through commercial launch.
- Partner with cross-functional teams to ensure design control and risk management requirements are effectively implemented.
- Oversee design reviews, risk assessments, verification and validation activities, and design transfer readiness.
- Drive quality input into product requirements, design outputs, specifications, and development documentation.
- Ensure compliance with applicable FDA regulations, ISO standards, and internal quality system requirements.
- Support development and execution of product risk management activities, including hazard analysis and FMEA reviews.
- Review and approve design control deliverables and quality-related documentation.
- Lead quality investigations, root cause analyses, and CAPA activities related to product development and design performance.
- Collaborate with Regulatory Affairs on product submissions and regulatory strategy support.
- Develop quality metrics and provide recommendations to improve product development effectiveness and compliance.
- Manage, mentor, and develop Design Quality Engineers and other quality professionals.
- Influence technical and business decisions through risk-based quality leadership.
Qualifications
- Bachelor's degree in Engineering, Biomedical Engineering, Mechanical Engineering, or related technical discipline.
- Approximately 10-15 years of experience within the medical device industry, including significant Design Quality, Design Assurance, or Product Development Quality experience.
- Prior people leadership, project leadership, or technical leadership experience.
- Strong knowledge of design controls, risk management, verification and validation, and product development processes.
- Experience working within FDA-regulated and ISO-compliant quality systems.
- Demonstrated ability to provide quality leadership across multiple cross-functional teams and programs.
- Strong analytical, problem-solving, and decision-making skills.
- Excellent communication, collaboration, and stakeholder management abilities.
Preferred Experience
- Class II or Class III medical device development experience.
- Experience supporting global product development programs.
- Familiarity with FDA submissions, regulatory inspections, and external audits.
- Experience utilizing risk management tools such as FMEA, hazard analysis, and fault tree analysis.
- Background supporting design transfer, process validation, and manufacturing readiness activities.
- Six Sigma, Lean, or quality engineering certifications.
- Experience leading quality engineering teams within a product development environment.
Key Competencies
- Design Assurance Leadership
- Risk Management
- Design Controls
- Product Development Quality
- Verification & Validation
- Regulatory Compliance
- Cross-Functional Leadership
- CAPA & Root Cause Analysis
- Strategic Decision Making
- Team Development & Mentorship
- Continuous Improvement
- Stakeholder Influence
FAQs
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