RESPONSIBILITIES:
- Establish and lead Advanced Product Quality Planning (APQP) frameworks tailored for regulated industries
- Define quality strategies aligned with business growth and new market expansion
- Drive risk-based methodologies (FMEA, CTQs, control plans) across product and process development
- Align internal and supplier quality expectations with customer and regulatory requirements
- Lead quality execution across the NPI lifecycle: concept, design, validation, launch, post-launch monitoring
- Ensure robust design transfers into manufacturing and supply chain
- Oversee:
- Design controls and technical reviews
- Process validation (IQ/OQ/PQ)
- First Article Inspection (FAI) and PPAP (as applicable)
- Drive Right First Time (RFT) and First Pass Yield (FPY) for new product launches
- Develop and execute a strategic supplier development program aligned with business growth and NPI requirements
- Lead supplier engagement early in NPI to ensure:
- Design for manufacturability (DFM)
- Process capability and scalability
- Risk mitigation in critical components
- Establish supplier segmentation and performance management
- Strategic, critical, and transactional suppliers
- Drive supplier qualification and onboarding processes including:
- Audits and capability assessments
- Process validation alignment (IQ/OQ/PQ where applicable)
- Implement supplier quality tools:
- Supplier APQP
- PPAP/FAI
- Supplier FMEA and control plans
- Lead supplier performance improvement initiatives based on:
- Supplier PPM
- On-time delivery
- Cost of Poor Quality (COPQ)
- Drive First Article Inspection (FAI) and PPAP development.
- Lead qualification and onboarding of new suppliers aligned with NPI timelines.
- Develop supplier capability through Process audits, technical assessments, and Quality System evaluations (ISO 9001/ISO14001, etc.)
- Establish supplier performance metrics: Supplier PPM, On-time Delivery, Cost of Poor Quality (COPQ)
- Partner with Supply Chain to develop long term supplier partnerships and dual sourcing strategies
- Drive corrective actions and continuous improvement with suppliers using structured methodologies (8D, DMAIC)
- Ensure NPI and supplier development processes are fully integrated into the QMS and aligned with:
- ISO 9001
- ISO 13485
- FDA regulations (be, 21 CFR Part 82)
- Standardize and enforce procedures:
- Design control
- Supplier quality management
- Change management (including supplier changes)
- CAPA processes
- Ensure audit readiness across internal operations and supplier base
- Ensure compliance across core industries (Biopharma, Lab & Medical)
- Collaborate with Regulatory Compliance teams on:
- Product and material compliance (RoHs, REACH, CMRT,PFAS considerations)
- Supplier regulatory requirements and documentation
- Monitor evolving regulatory requirements impacting products and suppliers
- Lead collaboration across: Engineering, Manufacturing & Operations, Supply Chain & Procurement and Regulatory Compliance
- Integrate suppliers into the broader ecosystem strategy (Technology, Service, Innovation Collaborators)
- Support co-development initiatives with key suppliers and customers
- Manage and co-develop ecosystem approach through affiliations and regulators to drive core industry focus markets
*This job description indicates the general nature and level of work expected. It is not designed to cover and contain a comprehensive listing of activities, duties or responsibilities required by the employee. Employee may be asked to perform other duties as required.*
REQUIREMENTS:
- Bachelor's degree in engineering, Quality, or related field (master's preferred)
- Six Sigma Green or Black Belt certified (a plus)
- 10+ years in Quality Assurance within manufacturing environments
- Experience in regulated industries preferred: Pharma/Biotech, Food & Beverage, Lab & Analytical/Medical Devices
- APQP, PPAP, FMEA, Control Plans
- Root cause analysis (8D, 5 Whys, Fishbone)
- Statistical analysis and digital quality systems (SPC, Cp/Cpk)
- Quality Management Systems (ISO 9001/ISO 13485- a plus)
- Supplier auditing and development
- Risk management frameworks
- Strong project management and program skills
- Strategic/data driven decision making
In return, we offer you exciting and challenging responsibilities, diverse perspectives with a high degree of individual freedom and a corporate culture that encourages you to use it.
