Posted on: August 4, 2022
Overview Quality Manager 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 Internal
and Supplier Audits and support Customer Audits. 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. Proficient knowledge of performing on
machined parts based on drawing requirements using precision
measuring tools. Proficient working knowledge of sampling plan(s).
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. Support and manage First Article Inspection
(FAI). 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 Qualifications/Skills: Two-year technical degree or
equivalent from an accredited technical institution is preferred. 3
years management experience with skills overseeing large team
environments Minimum 5 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.
Keywords: Repligen, Billerica , Quality Manager, Executive , Billerica, Massachusetts
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