Quality Manager

2 weeks ago

Shrewsbury, Massachusetts, United States Repligen Full time

Overview:

The Quality Manager will report directly to the Associate Director of Quality Assurance.

This position is responsible to actively participate in the Repligen ISO 9001 Quality Management System. This role is

responsible for the management of Quality Inspectors and QA Associates in support of material inspection and release. The Quality Manager will manage, mentor, and motivate their direct reports. They are responsible for supervising the daily schedule and assigning tasks to their direct reports. Must work independently and manage short and long-term priorities.

They will work closely with the manufacturing team assisting with Quality Management Systems such as non-conforming materials, deviations, and corrective actions. Demonstrates good judgement in selecting methods and techniques for obtaining solutions.

Responsibilities:
  • Manage the timely release of Incoming Inspection materials to maintain departmental goals. Ability to schedule activities to meet the priorities of Manufacturing requirements.
  • Manages direct reports which includes, setting objectives, monitoring performance, and conducting reviews.
  • Works with Subject Matter Experts, area managers and inter-departmental personnel to effectively manage and execute follow up on corrective actions, deviations and non-conformances, complaints.
  • Lead Customer, Internal and Supplier Audits.
  • Support all aspects of Change Control from creation to review.
  • Gathering of KPIs for daily tier meetings, weekly and monthly senior management meetings.
  • Able to assess and interpret engineering drawings, specifications, purchase orders, statement of work and standards to determine quality status.
  • Own and support any non-conforming material reports including Root Cause Investigations to closure.
  • Identify and lead continuous improvement opportunities for the quality program for customers internal and external.
  • Ensure calibration/ PM is maintained and up to date.
  • Maintain clean and orderly work area/ station.
  • Comply with safety regulations and personnel policy.

Other duties as assigned.

Qualifications:
  • Two-year technical degree or equivalent from an accredited technical institution is preferred.
  • 3-5 years management experience with skills overseeing large team environments
  • Minimum 5-7 years experience in Quality Assurance in an ISO 9001 certified Quality Management System or equivalent.
  • Familiar with medical devices, bioprocessing equipment, military or aerospace industry inspection practices and standards.
  • Requires demonstrated understanding of inspection tools (i.e.: Calipers, Micro-hite, Comparator etc.)
  • Requires proficient use of Microsoft Office tools (Outlook, Excel, Word (SAP, preferred)).
  • Strong communication with multiple departments and associates.
  • Ability to contribute to project teams such as change controls, 5S, operational excellence.
  • Focus and attention to detail is critical.
  • Strong knowledge of Good Documentation Practices preferred.

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