EVCO Plastics is a privately owned custom injection molding company located 15 minutes north of Madison in DeForest. EVCO Plastics is ISO 9001 & 13485 certified and is searching for a Quality Assurance Manager for our medical device contract manufacturing facility.

Requirements / Experience:

  • BS/BA in science related field or five years’ experience in medical laboratory QA/QC setting
  • A working knowledge of pharmaceutical / medical device manufacturing / cGMP
  • A working knowledge of bio-burden measuring and maintenance levels and clean room particulate testing
  • A working knowledge of FDA 21 CFR part 820 and ISO 13485
  • Experience in operating within a Class 8 Clean Room
  • Strong verbal, interpersonal, written and organizational skills
  • Previous Supervisory / leadership experience
  • Strong MS Office skills
  • Strong background in Geometry & Statistics
  • SPC & analytical reporting a plus
  • PPAP/ APQP / IQ, OQ, PQ knowledge
  • Working knowledge of GD&T
  • CAPA
  • No previous plastic injection molding experience necessary
  • ASQ/CQE preferred

RESPONSIBILITIES:

  • Coordinate ISO certification and customer audits as well as regulatory inspections, follow-up reporting to agency, and coordination and implementation of corrective action plans with all departments.
  • Develop and implement quality programs, meeting FDA, cGMP, and ICH guidelines for the manufacturing of medical device products.
  • Review and evaluation of control documents, analytical results trending to assure specifications for the acceptance of components, in-process, finished products, stability, and validation content.
  • Review and evaluation of results for continuous improvement of quality processes and efficiencies.
  • Conduct internal audits and audits of contract services to include corrective action plan follow-up, monitoring, and results review.
  • Develop and control quality documents.
  • Lead corrective / preventive action teams.
  • Maintain gage calibration system.
  • Coordinate in process inspection, Batch Record review and product release.
  • Facilitate training of Quality Assurance team.
  • Maintain all Quality Assurance files and specification.
  • Coordinate statistical capability studies, and assure conformity with customer specifications in accordance to ISO standards.
  • Complete & Track Corrective and Preventative Actions.
  • Maintain Quality Systems and certifications.
  • Support product launches including APQP, PPAP and IQ, OQ, PQ.
  • Manage customer relationships.
  • Supervise and lead Quality Assurance Team.

To learn more about EVCO Plastics, visit our website at:

Interested candidates should submit a resume, salary history and cover letter to:

Equal Opportunity Employer. Employment Contingent on Successful Completion of Drug Test