Rochester Jobs

AP Professionals Published: September 25, 2017 (25 days ago)
Location
Rochester
Job Type
Category

Description

Quality Systems Engineer

Direct hire, east side location, 80 - 100K depending on experience

Responsibilities 

  • Drive the implementation of QMS tools and technologies to enhance compliance to current standards, regulations, and corporate requirements.
  • Contribute to and execute a strategy for the implementation of QMS initiatives.
  • Drive initiatives to improve usability of QMS procedures and instructions.
  • Facilitate improvements of the QMS and provide training in GMS and Good Manufacturing Practices (GMP).
  • Manage and improve the CAPA process acting as the sites CAPA coordinator.
  • Manage the internal audit process.
  • Host and follow up on notified body audits.
  • Project manager/representative on implementation of new eQMS activities.
  • Manage current paper and eQMS systems.
  • Create and coordinate creation of key procedures and processes based on feedback, set quality goals, and to ensure customer agreement fulfillment.
  • Support internal functional partners and ensure all aspects of the QMS are understood, implemented, and maintained.

Skills / Abilities

  • Well organized and structured.
  • Possess strong analytic and problem solving skills.
  • Excellent ability to write documents and describe processes and procedures.
  • Attention to detail with good understanding of the big picture.

Education / Experience

  • Bachelor's degree in science or technology, or equivalent three to five years' of experience.
  • Working experience with ISO 13485 required.
  • Working experience with medical device regulations¬†(i.e. MDD 93/42/EEC, FDA 21 CFR Part 820) preferred.
  • Experience in auditing techniques as well as interpreting and transforming requirements to practical implementation.
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