Quality Engineering Manager

We are seeking an experienced Manager of Quality Engineering to lead quality systems, quality engineering, and regulatory compliance activities for a high-volume manufacturing business unit within a leading medical device organization. This role is responsible for ensuring compliance with global regulatory requirements while driving continuous improvement initiatives that support production, quality, customer satisfaction, and business objectives.

Reporting directly to the Associate Director of Quality Management, this individual will serve as a key member of the Business Leadership Team (BLT), partnering closely with Operations, Manufacturing, Regulatory Affairs, and R&D to maintain world-class quality standards across molding, assembly, packaging, sterilization, and product release processes.

Key Responsibilities

Quality Leadership & Strategy

• Lead all Quality Engineering and Quality Systems activities for the assigned business unit.
• Develop and execute quality strategies aligned with corporate quality objectives and business goals.
• Serve as the quality representative for the business unit on all regulatory and quality system matters.
• Provide leadership to cross-functional teams in achieving quality, operational, and organizational objectives.

Regulatory Compliance & Quality Systems

• Ensure compliance with FDA, ISO, and other applicable global regulatory requirements.
• Lead and support customer, internal, and regulatory audits.
• Drive continuous improvement of quality systems, business processes, and product controls.
• Maintain and strengthen regulatory readiness across manufacturing operations.

Process Improvement & Manufacturing Support

• Lead CAPA initiatives focused on reducing customer complaints, non-conformances, waste, and product rejections.
• Support and oversee validation activities related to products, processes, materials, and equipment.
• Partner with manufacturing teams to improve process capability, product quality, and operational efficiency.
• Champion Lean Manufacturing and Six Sigma methodologies to drive measurable improvements.

Team Leadership & Development

• Manage, mentor, and develop Quality Engineers and Quality Representatives.
• Build organizational capability through coaching, training, and succession planning.
• Foster a culture of accountability, collaboration, compliance, and continuous improvement.
• Promote customer-centric thinking throughout the organization.

Business Partnership

• Collaborate closely with Operations, Manufacturing, R&D, Regulatory Affairs, and Corporate Quality teams.
• Support key business metrics including customer complaint reduction, quality performance, waste reduction, CAPA closure, continuous improvement projects, delivery performance, and operational excellence initiatives.
• Support a 24/7 manufacturing environment and help establish priorities in a fast-paced setting.

Qualifications

Required

• Bachelor's Degree in Engineering, Science, or a related technical field.
• Minimum of 5 years of quality experience, including at least 3 years within the medical device industry.
• Previous leadership experience managing quality teams.
• Strong knowledge of:
• Quality Systems
• CAPA
• Process and Product Validation
• Statistical Analysis
• FDA and ISO regulatory requirements
• Experience working in high-volume manufacturing environments.
• Excellent communication and leadership skills with the ability to influence all levels of an organization.
• Ability to prioritize effectively and perform under pressure.

Preferred

• Lean Manufacturing and/or Six Sigma certification or demonstrated experience.
• Experience interacting directly with regulatory agencies and external auditors.
• Strong background bridging quality and manufacturing operations to drive production and quality improvements.

Ideal Candidate

The ideal candidate will have a strong quality leadership background in high-volume medical device manufacturing and possess a deep understanding of how quality systems support production performance. This individual will be a hands-on leader who can effectively partner with manufacturing teams, drive continuous improvement initiatives, strengthen regulatory compliance, and develop high-performing quality organizations.

Compensation $120,000.00 to $135,000.00 dependent on experience