Manufacturing Quality Manager

SUMMARY

A manufacturing organization is seeking a hands-on Quality leader to strengthen quality systems, develop a high-performing team, and support reliable manufacturing execution. This position combines strategic leadership with regular engagement on the production floor, partnering across operations, engineering, supply chain, and technical teams to improve controls, resolve quality issues, and promote continuous improvement. The role will lead manufacturing quality activities while helping maintain strong audit and regulatory readiness.

RESPONSIBILITIES

• Lead, coach, and develop Quality team members through clear priorities, feedback, delegation, and professional development.
• Provide day-to-day Quality leadership for manufacturing operations, including floor support, issue escalation, product disposition, training, and timely resolution of production concerns.
• Oversee manufacturing quality systems and help ensure consistent integration of quality processes across related operations.
• Ensure quality requirements are maintained for incoming materials, in-process production, and finished product release.
• Strengthen manufacturing controls, inspection practices, sampling methods, acceptance criteria, and production documentation.
• Partner with Operations and technical teams on process validation, equipment qualification, calibration, maintenance interfaces, and implementation of changes.
• Lead investigations involving nonconformances, deviations, complaints, and recurring manufacturing issues, with emphasis on evidence-based root cause analysis and sustainable corrective action.
• Own and continuously improve CAPA activities, including prioritization, investigations, action plans, effectiveness checks, documentation, and timely closure.
• Use quality metrics and trend data to identify risk, improve process control, support right-first-time performance, and prevent recurrence.
• Support supplier quality through qualification, performance monitoring, corrective actions, escalations, and supplier audits.
• Lead or support internal audits, management review activities, document control, training records, risk management, and validation practices.
• Promote Lean and continuous improvement methods that reduce variation, simplify processes, and strengthen manufacturing controls.
• Maintain readiness for customer, certification, and regulatory inspections and coordinate manufacturing quality responses and follow-up actions.
• Communicate quality performance, risks, resource needs, and improvement priorities to employees and leadership.

QUALIFICATIONS

• Bachelor's degree in science, engineering, or a related discipline required; master's degree preferred.
• Minimum 7 years of related quality experience within medical device manufacturing.
• Minimum 3 years of team leadership or supervisory experience.
• Hands-on experience with manufacturing quality systems, nonconformance management, CAPA, investigations, root cause analysis, product release, audits, supplier quality, and validation or qualification activities.
• Working knowledge of medical device quality and risk-management requirements, including ISO 13485, FDA 21 CFR Part 820/QMSR, and ISO 14971 principles.
• Ability to translate quality requirements into practical manufacturing processes and decisions.
• Strong cross-functional communication, problem-solving, leadership, and change-management skills.
• Proficiency with Microsoft Office and ability to learn quality and manufacturing systems; ASQ certification is a plus.
• Ability to travel approximately 10%, including possible domestic and international travel.

BENEFITS

• Hybrid, full-time leadership opportunity with meaningful visibility across manufacturing and business operations.
• Opportunity to shape manufacturing quality strategy, strengthen quality culture, and directly influence product consistency and continuous improvement.
• Broad leadership exposure across manufacturing, engineering, supply chain, technical teams, and senior leadership.
• Professional growth through ownership of quality systems, team development, supplier quality, audit readiness, and manufacturing improvement initiatives.
• Comprehensive benefits package including medical, dental, and vision coverage, FSA, 401(k), paid time off, life and disability insurance, and leave programs.
• Eligible for a performance-based bonus plan.