Validation Engineer
Validation Engineer
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Job Description
The client is currently seeking a passionate and skilled Validation Engineer to join their team and contribute to their mission of delivering high-quality engineered solutions to our customers this role you will be responsible for Validation/PPAP Packages on new customer programs as well as ensuring compliance is applicable regulatory bodies and standards (ISOCFR 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 customers 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: DOEs FMEAs Process Flowcharts Control Plans Capability Studies and Gage R&Rs.
- 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.
Pay Range: $100k - $110k
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.
Employment Type
Full-Time
