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Weiss-Aug · 3 hours ago

Validation Engineer

Fairfield, NJ

Full-time

Onsite

Mid, Senior Level

$100K/yr - $110K/yr

5+ years exp

Weiss-Aug is a leading provider of advanced manufacturing and engineering solutions with a commitment to excellence and innovation. The Validation Engineer will be responsible for Validation/PPAP Packages on new customer programs, ensuring compliance with applicable regulatory bodies and standards, and supporting the Program Management team on medical device program launches.

Health CareMedical

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

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

Qualification

PPAP/Validation DeliverablesGMP/ISO/21 CFR 820Technical WritingMinitabStatistical Process ControlQuality Inspection ToolsTQM/Six Sigma/LeanBlueprint ReadingMicrosoft OfficeCommunication Skills

Required

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

Knowledge of quality inspection tools and methods required

Knowledge of GMP/ISO/21 CFR 820 Quality Systems required

Strong technical writing skills

Proficient in Microsoft Word, Excel, and PowerPoint

Excellent verbal and written communication skills