SUMMARY:

The Senior Manager, Supplier Quality & Process Engineering is responsible for leading the development, implementation, and oversight of supplier management and manufacturing process quality systems that ensure compliance with regulatory standards (e.g., 21 CFR 820, ISO 13485) and meet business performance goals. This role will manage the qualification and performance of suppliers, execution of supplier audits, implementation of supplier quality agreements, and deployment of robust process validation strategies (IQ/OQ/PQ) across the product lifecycle. The role serves as a cross-functional leader and subject matter expert, bridging Supplier Quality, Procurement, Manufacturing, and Regulatory Affairs to ensure reliable, compliant, and cost-effective sourcing and production operations.
Responsibilities:
Essential Duties & Responsibilities:

The following statements are intended to describe the general nature and level of work being performed by an individual assigned to this job. Other duties may be assigned.

• Lead Supplier Quality Management: Oversee supplier qualification, performance monitoring, risk assessment, and issue resolution to ensure product quality and regulatory compliance.
• Manage Supplier Audits & Agreements: Conduct supplier audits, maintain audit schedules, and ensure robust Supplier Quality Agreements are in place and regularly updated.
• Drive Supplier Categorization & Qualification: Implement and maintain a risk-based supplier classification system and manage initial and ongoing qualification processes.
• Oversee Process Validation Activities: Lead development and execution of validation strategies (IQ/OQ/PQ) for internal and supplier manufacturing processes.
• Drive effective root cause analysis and timely closure of supplier related NCs, SCARs, and when applicable CAPAs related to supplier or process failures.
• Collaborate Cross-Functionally: Partner with Procurement, Manufacturing, R&D, and Quality teams to align supplier and process strategies with business objectives.
• Support Technology Transfers & Change Control: Provide quality and validation leadership for new product launches, tech transfers, and supplier-driven changes.
• Develop and Report KPIs: Establish and monitor key performance indicators related to supplier quality and process validation for management review.
• Demonstrated leadership skills with experience managing teams and collaborating cross-functionally
• Experience leading supplier audits, managing supplier quality agreements, and implementing SCAR/CAPA processes
• Perform other quality-related duties assigned by management, including but not limited to supporting CAPA investigations, data analysis, and continuous improvement initiatives.
• Occasional travel may be required to support product development activities, supplier visits, or audits.

EDUCATION AND EXPERIENCE:

• BS Degree or higher in science field required (e.g., Industrial Engineering, computer system, Life Sciences).
• Minimum 7 years’ experience in medical device manufacturing, or validation or supplier relations.

Knowledge, Skills, and Abilities:

• A practical and working knowledge of ISO 13485, 21 CFR 820 (preferred)
• Experience with Design Controls
• Statistical knowledge and understanding of measurement uncertainty (preferred)
• Detail oriented, well organized and have excellent communication skills
• Able to accomplish objectives with minimal supervision

The following statements are intended to describe the general nature and level of work being performed by an individual assigned to this job. Other duties may be assigned.

• Lead Supplier Quality Management: Oversee supplier qualification, performance monitoring, risk assessment, and issue resolution to ensure product quality and regulatory compliance.
• Manage Supplier Audits & Agreements: Conduct supplier audits, maintain audit schedules, and ensure robust Supplier Quality Agreements are in place and regularly updated.
• Drive Supplier Categorization & Qualification: Implement and maintain a risk-based supplier classification system and manage initial and ongoing qualification processes.
• Oversee Process Validation Activities: Lead development and execution of validation strategies (IQ/OQ/PQ) for internal and supplier manufacturing processes.
• Drive effective root cause analysis and timely closure of supplier related NCs, SCARs, and when applicable CAPAs related to supplier or process failures.
• Collaborate Cross-Functionally: Partner with Procurement, Manufacturing, R&D, and Quality teams to align supplier and process strategies with business objectives.
• Support Technology Transfers & Change Control: Provide quality and validation leadership for new product launches, tech transfers, and supplier-driven changes.
• Develop and Report KPIs: Establish and monitor key performance indicators related to supplier quality and process validation for management review.
• Demonstrated leadership skills with experience managing teams and collaborating cross-functionally
• Experience leading supplier audits, managing supplier quality agreements, and implementing SCAR/CAPA processes
• Perform other quality-related duties assigned by management, including but not limited to supporting CAPA investigations, data analysis, and continuous improvement initiatives.
• Occasional travel may be required to support product development activities, supplier visits, or audits