Validation Engineer – Medical Device Quality & PPAP Lead

Weiss-Aug Co.; Fairfield (NJ); Híbrido; USD 100.000 - 110.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical, Dental and Vision

401 (k) with company match

Holiday, Vacation and Sick Time

Tuition Reimbursement

Health Savings Accounts (HAS)

Flexible Spending Accounts (FSA)

Cigna Wellness Incentive Program

Employee Assistance Program (EAP)

Short Term Disability

Group Life and Accidental Insurance

Sun Life – Accident, Critical Illness,

Smoking Cessation Program

Pet Insurance

Descripción de la vacante

Weiss-Aug in Fairfield, NJ seeks a Validation Engineer to lead PPAP/Validation deliverables for new programs, ensuring ISO13485, 21 CFR 820, GMP compliance. You will write IQ/OQ/PQ protocols, support APQP docs, and drive quality improvements across programs.

The role requires a 4-year engineering degree and medical device quality experience, with opportunities to contribute to innovative, vertically integrated manufacturing solutions in the US.

Formación

• Minimum of 5 years in product quality with PPAP/Validation deliverables.
• Experience in medical device/life sciences (GxP) industry required.
• Ability to read blueprints and GD&T; ANSI/ISO standards knowledge.
• Proficient in MS Word, Excel, and PowerPoint; strong technical writing.

Responsabilidades

• Lead Master Validation Reports and IQ/OQ/PQ protocol execution.
• Manage PPAP/Validation completion and APQP documentation.
• Prepare SOPs and technical writing for new programs.
• Ensure GMP/ISO13485 and 21 CFR 820 compliance; audit readiness.
• Support program launches and customer quality expectations.

Conocimientos

PPAP/Validation Deliverables

GxP Knowledge

Statistical Analysis (SPC/GR&R/MSA)

Technical Writing

MS Office

Educación

Four-year Engineering Degree

Herramientas

Minitab

ERP/MRP software

Descripción del empleo

Weiss-Aug in Fairfield, NJ seeks a Validation Engineer to lead PPAP/Validation deliverables for new programs, ensuring ISO13485, 21 CFR 820, GMP compliance. You will write IQ/OQ/PQ protocols, support APQP docs, and drive quality improvements across programs.

The role requires a 4-year engineering degree and medical device quality experience, with opportunities to contribute to innovative, vertically integrated manufacturing solutions in the US.