Validation Engineer

3 weeks ago

Fairfield, United States Weiss-Aug Group Full time

Job Type

Full-time

Description

Weiss-Aug Group is an internationally recognized leader in precision metal stamping, injection molding, value-added assembly solutions and tooling.

Our Surgical Products Division serves the medical device industry and has created special capabilities for the manufacture of surgical instruments. With expansive technology in R&D, laser processing, insert molding, production machining, we need the best minds to serve our customers and ultimately patients around the world.

Join our team where every day we push the boundaries of manufacturing technology to help our customers produce the best medical devices so that people may live healthier lives.

The Validation Engineer position is responsible for Validation/PPAP Packages on new customer programs, as well as ensuring compliance is applicable regulatory bodies and standards (ISO13485, 21 CFR 820, GMP).

Responsibilities:

  • Responsible for Master Validation Reports, including writing and execution of IQ, OQ, PQ Protocols
  • Works independently, taking lead on PPAP / Validation Completion. Leads team to provide deliverables, and takes initiative to proactively management the PPAP Process, including all applicable APQP documentation.
  • Responsible for SOP and Technical Writing for New Programs
  • Must have practical knowledge of GMP, ISO13485, and/or 21 CFR 820 Compliance
  • Represent the customer in order to ensure that the customer's quality expectations are clearly understood and being met.
  • Support Program Management team on launch and management of medical device programs.
  • Advanced Product Quality Planning (APQP) including completion of related documentation, including but not limited to: DOE's, FMEA's, Process Flowcharts, Control Plans, Capability Studies and Gage R&R's.
  • Ability to participate in product design (R&D) meetings with Medical Customers in relationship with understanding key quality deliverables.
  • Oversee the development and input of initial BOM and detailed Routing
  • Oversee the initiation and/or coordination of the change control process (ECO) relating to Engineering documentation.
  • Primary auditee responsible for Validation, PPAP, APQP Packages to third party auditors.
  • Ability to Understand Statistics as related to SPC, GR&R, MSA Studies
  • Lead-in customer, internal and registrar quality system audits.
Requirements
  • Minimum of 5 yrs. (equivalent) experience in product quality position, with direct experience PPAP/Validation Deliverables. Experience in medical device/life science (GxP) industry required.
  • Requires a 4-yr engineering degree or substitute experience; graduate degree in engineering, technical or management discipline is preferred.
  • Ability to read blueprints and other technical documents. Understanding of ANSI/ISO drawing standards and GD&T dimensioning required.
  • Ability to uses Minitab preferred.
  • Knowledge of quality inspection tools and methods required. Familiarity with Statistical Process Control (SPC) tools and methods also preferable.
  • Knowledge of GMP/ISO/21 CFR 820 Quality Systems required.
  • Knowledge of TQM, Six Sigma or Lean Manufacturing principles preferable.
  • Knowledge of progressive metal stamping and/or insert molding processes desirable.
  • Strong technical writing skills.
  • Proficient in Microsoft Word, Excel, and PowerPoint.
  • Knowledge or MRP or ERP software preferable.
  • Excellent verbal and written communication skills.

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