Supplier Quality Manager

Company Overview:

• Merrimack Manufacturing is a medical device manufacturer located in the Manchester Millyard.
• We are a growing manufacturing company that will play a crucial part in bringing innovative and life changing products to life.

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. Powered by JazzHR