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 improvementDevelop and execute supplier quality strategies to ensure compliance with business, customer, and regulatory requirementsOwn supplier qualification, onboarding, and performance management processes, including supplier selection, audits, risk assessments, and approval activitiesEstablish and maintain supplier governance programs, including Approved Supplier Lists (ASL), supplier risk management, quality agreements, and performance scorecardsDrive supplier performance improvements through effective management of audits, SCAR/CAPA systems, root cause investigations, and continuous improvement initiativesServe as the escalation point for critical supplier quality, compliance, and supply continuity issues, ensuring timely resolution and risk mitigationLead Supplier Review Board (SRB) activities, including supplier performance reviews, risk assessments, escalation decisions, and action planningEnsure supplier compliance with applicable quality system requirements, including ISO 13485, FDA, EU MDR, and other relevant regulatory standardsPartner cross-functionally with Engineering, Manufacturing, Supply Chain, Procurement, and Product Development to support supplier selection, product launches, design transfers, and lifecycle managementProvide supplier quality leadership for new product introductions (NPI), supplier changes, transfer activities, and business continuity planningDevelop, monitor, and report supplier quality metrics and KPIs to drive data-based decision making and organizational performanceSupport 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 industry3+ years of leadership experience managing or leading SQE teams or supplier quality functionsStrong experience with supplier qualification, audits, and global supply chain quality managementDemonstrated experience supporting NPI, design transfer, and process validation activities with external suppliersStrong knowledge of ISO 13485, FDA 21 CFR Part 820 and global regulatory requirementsDeep understanding of manufacturing processes, process validation, and supplier process controlsExperience with contract manufacturers and global supply chain structuresKnowledge of risk management tools (FMEA), CAPA systems, and statistical quality methodsStrong problem-solving and root cause analysis skills (e.g., 8D methodology)Proficiency with supplier performance metrics and quality analyticsProven ability to lead and develop technical teams in a regulated environmentStrong decision-making and escalation management skillsAbility to influence cross-functional and external stakeholders at all organizational levelsExcellent communication, negotiation, and supplier relationship management skillsStrategic 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 8Roi6vd4aH