Validation Engineer

Job Title

Validation Engineer

Fairfield, NJ, US

Experience: Mid Level

Salary: $100,000 - $110,000 per year

• 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, ISO
  13485, 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

• Minimum of 5 years 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 use 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

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 (ISO
13485, 21 CFR 820, GMP)

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