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Position title
PPAP/Validation Engineer
Responsibilities
  • Represent the customer 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.
  • Responsible for SOP and Technical Writing for New Programs
  • Responsible for Master Validation Reports, including writing and execution of IQ, OQ, PQ Protocols
  • Must have practical knowledge of GMP, ISO13485, and/or 21 CFR 820 Compliance
  • Ability to Understand Statistics as related to SPC, GR&R, MSA Studies
  • Participate in customer, internal, and registrar quality system audits.
Education

Requires a 4-yr engineering degree or substitute experience; a graduate degree in engineering, technical, or management discipline is preferred.

Qualifications
  • Minimum of 5 yrs. experience in product quality position, with direct experience in quality system compliance. Experience in medical device/life science (GxP) industry required.
  • Ability to read blueprints and other technical documents. Understanding of ANSI/ISO drawing standards and GD&T dimensioning required.
  • Ability to use SolidWorks for product/tooling design preferable.
  • 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.
  • Exceptional analytical and computational skills. Knowledge of problem-solving tools and techniques preferable.
  • Excellent verbal and written communication skills.
  • Demonstrated high level of creativity and innovation.
  • Demonstrated decision-making capability
Employment Type
Full-time
Job Location
6 Daniel Road, Fairfield, NJ, 07004
Date posted
May 25, 2022
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Position: PPAP/Validation Engineer

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