Validation Engineer Needed For Leading Medical Device Manufacturer

About Us

My client is a leading medical device manufacturing company and is growing! They are looking to add a Validation Engineer who will be 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).

Why Join Us?

• Compensation Up To $110,000
• Medical, Dental and Vision
• 401 (k) with company match
• Holiday, Vacation and Personal Time Off
• Tuition Reimbursement
• Employee Assistance Program (EAP)
• Short Term Disability
• Group Life and Accidental Insurance

Job Details

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.

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.