Director, Design Quality
$144,500–$187,000 year
On-siteQuality, Georgia, United States
Job Summary
Lead a team of Design Quality Managers and Engineers to execute the New Product Development, Reliability Engineering, and Sustaining Engineering processes, ensuring projects meet quality, cost, and delivery objectives. Develop and execute the organization's Design Quality Assurance strategy, establishing a Center of Excellence to drive standardization and continuous improvement across development and sustaining programs. Oversee risk management processes, conduct product risk assessments, and direct Reliability Laboratory operations including test scheduling, equipment qualification, and data integrity. Partner with R&D, Manufacturing, Regulatory Affairs, and other cross-functional teams to proactively identify and mitigate product risks, lead investigations into design-related field issues, and ensure compliance with FDA QSR, ISO 13485, ISO 14971, EU MDR, and MDSAP standards. Recruit, develop, and retain a high-performing Design Quality team while providing strategic leadership to executive management on product quality and regulatory matters.
Required Qualifications
- Bachelor's degree in Engineering or related technical discipline
- Minimum 10 years of progressive experience in Quality, Design Assurance, Product Development, or Engineering within a regulated industry
- Demonstrated expertise in Design Controls
- Demonstrated expertise in Risk Management
- Demonstrated expertise in Reliability Engineering
- Demonstrated expertise in Quality Systems
- Demonstrated expertise in Product Development Processes
- Demonstrated expertise in CAPA and Root Cause Analysis
- Extensive knowledge of FDA, ISO 13485, ISO 14971, MDSAP, and applicable global regulations
- Proven ability to lead organizational change and continuous improvement initiatives
- Exceptional leadership manifested through organizing and motivating teams toward their respective goals by employing hands-on management
- The ability to work hard and deliver results under pressure, as well as the willingness to address and shift priorities in rapidly changing markets
Desired Qualifications
- Master's degree in Engineering, Quality, or Business Administration
- Medical device industry experience
- Experience working within an R&D environment and NPD programs
- Experience leading global or multi-site Quality organizations
- Experience with statistical analysis software
- Project Management Professional (PMP) Certification
- Excellent project management skills and ability to manage multiple high priority situations at once
- Excellent problem-solving skills
- Focus on identification of potential issues and continuous improvement
- Experience working on cross-functional teams and on own initiative
- Demonstrated leadership skills including conflict resolution, assertiveness, and negotiation skills
- Experience in successfully coordinating with cross-functional departments, (e.g. Legal, Regulatory, Operations, Supply Chain, Scientific Affairs, Marketing, Quality, Service, Etc.)
- Demonstrated ability to make sound data driven business decisions
- Strong attention to detail
- Demonstrated excellent organizational, oral, and written communications skills
- Must have PC experience, as well as working familiarity of desktop applications including Excel, Word, and PowerPoint
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