Manager, Manufacturing Quality, Medical OEM

Quality & Compliance & Validation & Metrology

Work location to include Budd Lake, NJ and Parsippany, NJ.

The Manager, Manufacturing Quality is a visible, hands‑on leader who builds a strong quality and compliance culture for OEM, develops people, strengthens manufacturing controls, and partners across Operations, Engineering, Supply Chain, and the broader OEM network. This role offers the opportunity to shape how quality enables reliable execution, continuous improvement, customer confidence, and sustainable growth. The position will own and advance the manufacturing quality system for OEM, Inc, including leading and development of quality team members.

They will act as Quality Management Representative for OEM Inc. and Deputy Management Representative for OEM North America. The role combines strategic leadership with practical floor-level engagement, using data, risk‑based thinking, and structured problem solving to prevent issues, improve capability, and deliver dependable product quality. This role will provide regulatory support as needed, while the primary focus remains manufacturing excellence.

• Lead, coach, and develop Quality team members through clear priorities, regular feedback, effective delegation, and meaningful growth opportunities.
• Create an energized, accountable quality culture in which employees understand requirements, raise concerns early, and participate in solutions.
• Serve as an influential member of the site leadership team, translating quality priorities into practical manufacturing plans and measurable results.
• Build strong partnerships with Manufacturing, Supply Chain, R&D, and affiliated Quality teams to align decisions, remove barriers and standardize practices across OEM companies.
• Communicate quality performance, risks, resource needs, and improvement priorities clearly to employees and senior leadership.
• Lead through change by establishing direction, engaging stakeholders, employ automated workflows, and sustaining new ways of working.

• Provide day-to-day Quality leadership for manufacturing operations at OEM Inc., including floor presence, escalation support, disposition decisions, QMS training, and timely resolution of production issues.
• Manage the QMS integration between OEM Inc. and OEM North America.
• Ensure quality requirements are met for incoming materials, in-process activities, and final release of manufactured products.
• Maintain responsibility for final product release.
• Strengthen production controls, inspection methods, acceptance criteria, sampling approaches, and manufacturing documentation to support consistent execution.
• Partner with Operations and R&D on process validation, equipment qualification, calibration, maintenance interfaces, and change implementation.
• Lead investigations of nonconformities, deviations, complaints, and recurring manufacturing issues. Ensure root causes are evidence‑based and actions are effective.
• Own and improve the CAPA system, including prioritization, investigation quality, action planning, effectiveness checks, timeliness, and lean documentation.
• Use quality metrics and trend data to identify risk, focus resources, improve right-first-time performance, and prevent recurrence.
• Drive supplier quality activities, including qualification, performance monitoring, issue escalation, corrective action, and supplier audits, in partnership with Supply Chain.
• Lead internal audit activities and management review inputs with an emphasis on manufacturing performance, system effectiveness, risk, and improvement opportunities.
• Maintain effective document control, training, records, risk…