Finish Line Staffing Services
Description
Position Summary
The Sr. Director, Design and Supplier Quality Assurance provides global leadership for NPI design controls, design transfer, and the validation, maintenance, and continuous improvement of both CMO production and supplied materials. This role holds direct accountability for Design Quality (DQA), Supplier Quality (SQA), Test Method Validation (TMV), Computer System/Software (non-product) Validation (CSV), labeling and sterilization compliance, and periodic/ad-hoc risk reviews.
Key Responsibilities:
- Lead through company values and reinforce a strong, global Quality Culture.
- Build a culture of accountability, action, and on-time delivery.
- Set SMART goals, provide coaching and feedback, and mentor team members for career growth.
- Preserve effective relationships even in dynamic or challenging circumstances.
- Demonstrate hands-on leadership and a commitment to continuous improvement.
- Establish and communicate a zero-defects vision aligned with company strategy and objectives.
- Maintain global accountability for Design & Supplier Quality performance, sterilization/labeling compliance, and successful design transfer.
- Share accountability with Quality Systems (QS) and Regulatory Affairs (RA) for maintaining a compliant, effective global Quality Management System (QMS).
- Support integration of new acquisitions into the global QMS.
- Partner across functions to drive operational excellence, create synergies, and achieve business goals.
- Collaborate with Procurement to define supplier performance metrics and implement corrective actions.
- Work closely with Field Service to understand customer issues and support product/process improvements.
- Participate in Management Review preparation and leadership.
- Identify market trends and emerging customer needs to inform quality strategy.
- Lead risk-based planning and contingency development to support AOP/LT goals.
- Implement external and internal best practices to optimize processes.
- Champion digital and AI/ML-enabled solutions to automate manual processes, accelerate quality data analysis, enhance trend detection, and uncover deeper correlations.
- Lead and support CAPA activities end-to-end.
- Maintain expertise in statistical analysis, sampling plan development, and advanced problem-solving tools.
- Establish supplier process controls aligned with a zero-defects philosophy (e.g., FMEA, control plans, verification/validation, risk engineering).
- Define supplier classifications and control levels based on risk.
- Support Quality and Sustaining Engineering with project assignments and technical deliverables.
Qualifications:
- Bachelor’s degree in engineering or related field; 15+ years of medical device experience with 12+ years in quality/regulatory/compliance leadership.
- Strong understanding of global medical device regulations and standards, especially MDSAP, MDR, and APAC requirements.
- Proven experience in project planning, execution, reporting, and closure.
- Proficiency with process development tools (FMEA, validation, control plans, etc.).
- Demonstrated ability to lead root cause analysis; experience with capital equipment (mechanical/electrical) is a plus.
- Strong track record of leading and influencing cross-functional teams.
- High-level project management experience preferred.
- Comfortable operating in a high-performance, fast-paced environment.
- Knowledge of AI/ML techniques and digital transformation concepts is a plus.
- Strong analytical, hypothesis-driven, and data-based decision-making skills.
- Excellent verbal and written communication skills, including with senior leadership, customers, and regulators.
- Proven leadership capabilities, especially during times of ambiguity or change.
- Proficiency in MS Office and familiarity with enterprise systems, query tools, ServiceMax, and Oracle is a plus.