Manager, Manufacturing Quality

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.