Senior Supplier Quality Leader: NPI & Compliance

Merrimack Manufacturing; Manchester (NH); On-site; USD 90,000 - 140,000; Full time

Job summary

Merrimack Manufacturing, a medical device manufacturer in the Manchester Millyard, seeks a Supplier Quality Manager to lead SQE and ensure ISO 13485 and FDA compliance across NPI and manufacturing. The role drives supplier qualification, performance management, and quality system compliance.

Responsibilities include audits, risk assessments, and governance programs, with cross-functional collaboration to support product launches and lifecycle management. 20–30% travel is anticipated.

Qualifications

• 7–10+ years in Supplier Quality or related roles within a regulated medical device or similar industry.
• 3+ years of leadership experience managing SQE teams or supplier quality functions.
• Strong experience with supplier qualification, audits, and global supply chain quality management.
• Experience supporting NPI, design transfer, and process validation with external suppliers.
• Deep knowledge of ISO 13485 and FDA 21 CFR Part 820 regulatory requirements.

Responsibilities

• Lead and develop the Supplier Quality team, driving accountability and continuous improvement.
• Develop and execute supplier quality strategies to ensure compliance with requirements.
• Own supplier qualification, onboarding, performance management, audits, risk assessments, and approvals.
• Establish and maintain supplier governance programs (ASL, risk management, scorecards).
• Drive improvements through audits, CAPA, root cause analysis, and corrective actions.
• Escalate critical supplier quality and supply continuity issues and mitigate risks.
• Lead SRB activities including supplier performance reviews and escalation decisions.
• Ensure compliance with ISO 13485, FDA, EU MDR and other standards.
• Collaborate with Engineering, Manufacturing, Supply Chain, Procurement, and Product Development.
• Provide supplier quality leadership for NPI, changes, and lifecycle management.
• Develop and report supplier quality KPIs for data-driven decisions.
• Support customer audits, regulatory inspections, and quality assessments.

Skills

Leadership

Supplier Quality

Audits

Regulatory Knowledge

Process Validation

Risk Management

CAPA

Data Analytics

Cross-functional Collaboration

Education

Bachelor’s degree in Engineering

Tools

QMS

CAPA systems

Job description

Merrimack Manufacturing, a medical device manufacturer in the Manchester Millyard, seeks a Supplier Quality Manager to lead SQE and ensure ISO 13485 and FDA compliance across NPI and manufacturing. The role drives supplier qualification, performance management, and quality system compliance.

Responsibilities include audits, risk assessments, and governance programs, with cross-functional collaboration to support product launches and lifecycle management. 20–30% travel is anticipated.