Manager, Manufacturing Quality

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

Summary: The Manager, Manufacturing Quality is a visible, hands-on leader who builds a strong quality and compliance culture for DSRV, develops people, strengthens manufacturing controls, and partners across Operations, Engineering, Supply Chain, and the broader Stago 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 DSRV, Inc, including leading and development of quality team members. They will act as Quality Management Representative for DSRV Inc. and Deputy Management Representative for Stago 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.

Essential Duties & Responsibilities:

Leadership Accountabilities:
- 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 Stago 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.

Manufacturing Quality Responsibilities:
- Provide day-to-day Quality leadership for manufacturing operations at DSRV Inc., including floor presence, escalation support, disposition decisions, QMS training, and timely resolution of production issues.
- Manage the QMS integration between DSRV Inc. and Stago 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 management, and validation practices that support disciplined quality
- Champion Lean and continuous improvement methods that reduce variation, simplify work, strengthen controls, and improve the employee and customer experience.
- Ensure readiness for customer, certification, and regulatory inspections. Coordinate responses and follow-up actions related to manufacturing and Quality systems.
- Provide regulatory documentation or agency support as needed, in partnership with US Market Access.

-Serve as Management Representative for DSRV Inc. and Deputy Management Representative for Stago North America.

-Ensure Quality is integrated into daily manufacturing decisions instead of inspected in after the fact.

-Ensure issues are surfaced early, investigated thoroughly, and resolved with durable corrective action.

-Quality metrics drive focused action and demonstrate improving process control and product consistency.

-Ensure the site is consistently ready for audits and inspections because strong daily execution is the norm.

Education and/or Experience:

• Bachelor's Degree in science, engineering, or related field is required. Master's degree preferred.
• Minimum 7 years of related experience in a medical device manufacturing environment required.
• Minimum 3 years team leadership/supervisory experience required.
• Demonstrated experience with manufacturing quality systems, nonconformance, CAPA, investigations, root cause analysis, product release, audits, supplier quality, and validation or qualification activities required.
• Must possess working knowledge of applicable quality system standards and requirements, such as ISO 13485, FDA 21 CFR 820 (QMSR), and ISO 14971 risk management principles and the ability to apply requirements in a practical manufacturing environment.
• Proficiency with Microsoft Office applications and the ability to learn and use quality and manufacturing systems.
• ASQ certifications a plus.
• 10% travel. Must be able to travel both domestically and possibly internationally.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

We offer an extensive benefit and compensation package that includes medical, dental, vision, FSA, 401k, PTO, life and disability insurance, as well as a comprehensive leave program. Pay anticipated for this position in New Jersey is from $100,000 to $130,000, depending on a number of factors. This role is also anticipated to be eligible to participate in a bonus plan which is associated with this position. In the ordinary course of business, compensation and benefits programs may change based upon the Company’s needs.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, citizenship, disability or protected veteran status.