Medical Device Validation Engineer PPAP & GMP

Weiss-Aug; Fairfield (NJ); On-site; USD 100,000 - 110,000; Full time

Benefits offered by this job

Medical, Dental & Vision

401(k) with company match

Holiday, Vacation & Sick Time

Tuition Reimbursement

Health Savings Accounts (HSA)

Flexible Spending Accounts (FSA)

Wellness Incentive Program

Employee Assistance Program (EAP)

Job summary

Weiss-Aug is seeking a passionate Validation Engineer for their Fairfield, NJ site. You will prepare master validation documentation, ensure GMP/ISO13485/21 CFR 820 compliance, and drive PPAP/APQP activities across new medical device programs.

You will collaborate with cross-functional teams, lead audits, and ensure quality deliverables through robust validation and process control. This role demands strong technical writing and a solid engineering background.

Qualifications

• Minimum 5 yrs experience in product quality with PPAP/Validation deliverables.
• Experience in medical device/life science (GxP) industry.
• Ability to read blueprints and understand ANSI/ISO drawings and GD&T.

Responsibilities

• Prepare Master Validation Reports and IQ/OQ/PQ protocols.
• Lead PPAP/Validation completion and APQP documentation oversight.
• Write SOPs and technical documents for new programs.

Skills

GxP knowledge

Minitab

SPC

Technical writing

GD&T

MS Office

Quality systems

Education

4-year engineering degree

Tools

ERP/MRP software

Job description

Weiss-Aug is seeking a passionate Validation Engineer for their Fairfield, NJ site. You will prepare master validation documentation, ensure GMP/ISO13485/21 CFR 820 compliance, and drive PPAP/APQP activities across new medical device programs.

You will collaborate with cross-functional teams, lead audits, and ensure quality deliverables through robust validation and process control. This role demands strong technical writing and a solid engineering background.