Position Overview:The Supplier Quality Manager is responsible for leading the Supplier Quality Engineering (SQE) function and serving as the management representative for supplier quality within an ISO 13485-regulated medical device organization. This role provides strategic and operational leadership for supplier qualification, supplier performance management, and supplier quality system compliance across both New Product Introduction (NPI) and sustaining manufacturing operations.
The Supplier Quality Manager ensures that the organization's supply base consistently meets applicable regulatory requirements, including ISO 13485, FDA 21 CFR Part 820 and customer-specific requirements. This role acts as the primary escalation point for supplier quality issues and is responsible for driving supplier performance, compliance, and continuous improvement across the supply chain.
This is a full-time, on-site leadership position requiring regular interaction with cross-functional teams, suppliers, and manufacturing operations to support business objectives and ensure effective supplier quality management.
Responsibilities:- Lead and develop the Supplier Quality team, driving a culture of accountability, collaboration, and continuous improvement.
- Develop and execute supplier quality strategies to ensure compliance with business, customer, and regulatory requirements.
- Own supplier qualification, onboarding, and performance management processes, including supplier selection, audits, risk assessments, and approval activities.
- Establish and maintain supplier governance programs, including Approved Supplier Lists (ASL), supplier risk management, quality agreements, and performance scorecards.
- Drive supplier performance improvements through effective management of audits, SCAR/CAPA systems, root cause investigations, and continuous improvement initiatives.
- Serve as the escalation point for critical supplier quality, compliance, and supply continuity issues, ensuring timely resolution and risk mitigation.
- Lead Supplier Review Board (SRB) activities, including supplier performance reviews, risk assessments, escalation decisions, and action planning.
- Ensure supplier compliance with applicable quality system requirements, including ISO 13485, FDA, EU MDR, and other relevant regulatory standards.
- Partner cross-functionally with Engineering, Manufacturing, Supply Chain, Procurement, and Product Development to support supplier selection, product launches, design transfers, and lifecycle management.
- Provide supplier quality leadership for new product introductions (NPI), supplier changes, transfer activities, and business continuity planning.
- Develop, monitor, and report supplier quality metrics and KPIs to drive data-based decision making and organizational performance.
- Support customer audits, regulatory inspections, and quality system assessments related to supplier controls and supplier management processes.
This version is more concise, leadership-focused, and consistent with typical Supplier Quality Manager postings in the medical device and regulated manufacturing industries.
Qualifications and Skills:- 7-10+ years of experience in Supplier Quality, Quality Engineering, Manufacturing Quality, or related roles within a regulated medical device or similarly controlled industry.
- 3+ years of leadership experience managing or leading SQE teams or supplier quality functions.
- Strong experience with supplier qualification, audits, and global supply chain quality management.
- Demonstrated experience supporting NPI, design transfer, and process validation activities with external suppliers.
- Strong knowledge of ISO 13485, FDA 21 CFR Part 820 and global regulatory requirements.
- Deep understanding of manufacturing processes, process validation, and supplier process controls.
- Experience with contract manufacturers and global supply chain structures.
- Knowledge of risk management tools (FMEA), CAPA systems, and statistical quality methods.
- Strong problem-solving and root cause analysis skills (e.g., 8D methodology).
- Proficiency with supplier performance metrics and quality analytics.
- Proven ability to lead and develop technical teams in a regulated environment.
- Strong decision-making and escalation management skills.
- Ability to influence cross-functional and external stakeholders at all organizational levels.
- Excellent communication, negotiation, and supplier relationship management skills.
- Strategic thinker with strong operational execution capability.
- Ability and willingness to travel domestically and internationally (approximately 20-30%) for supplier visits, audits, assessments, and escalations.
Education: Bachelor's degree in Engineering, Life Sciences, or related technical discipline or equivalent combination of education and relevant experience.
