Validation Engineer

Validation Engineer Needed For Leading Medical Device Manufacturer

This Jobot Job is hosted by: Kevin Finlay
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Salary: $100,000 - $110,000 per year

A bit 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

Other Benefits Include

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.

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