Validation Engineer

Description

Join Weiss-Aug – A Leader in Precision Manufacturing and Innovation. Be part of a company that’s shaping the future of manufacturing where your ideas, skills, and passion matter.

Job Type: Full-time

Weiss-Aug is a leading provider of advanced manufacturing and engineering solutions with advanced facilities across the U.S. and Mexico for over 50 years. We specialize in high-volume metal stamping, thermoplastic molding, and value-added assembly solutions. Our Med Pharma division serves the medical device and life science industry, offering vertically integrated manufacturing solutions, partnered with in-house product design and engineering services.

At Weiss-Aug we are driven by a commitment to excellence, innovation, and continuous improvement. We provide a true single‑source supplier option to meet customers’ most challenging product innovation needs. With advances in materials science, specialty coatings, laser processing, and hybrid additive manufacturing technologies, we need the best minds in industry. Expanding our team brings fresh perspectives, ideas, and talent to enhance our solution offerings and support our technology roadmap, including finished drug‑delivery/combination devices and machined implants.

We’re currently seeking a passionate and skilled Validation Engineer to join our team and contribute to our mission of delivering high‑quality, engineered solutions worldwide. In this role you will be responsible for Validation/PPAP Packages on new customer programs, ensuring compliance with regulatory bodies and standards (ISO
13485, 21 CFR 820, GMP).

• Responsible for Master Validation Reports, including writing and execution of IQ, OQ, PQ protocols.
• Lead PPAP/Validation completion, managing the PPAP process and all applicable APQP documentation.
• Responsible for SOP and technical writing for new programs.
• Practical knowledge of GMP, ISO
  13485, and/or 21 CFR 820 compliance.
• Represent the customer to ensure quality expectations are understood and met.
• Support program management on launch and management of medical device programs.
• Advanced Product Quality Planning (APQP) including DOE’s, FMEA’s, process flowcharts, control plans, capability studies, and Gage R&R’s.
• Participate in product design (R&D) meetings with medical customers to understand key quality deliverables.
• Oversee development and input of initial BOM and detailed routing.
• Coordinate change control processes (ECO) related to engineering documentation.
• Primary auditee responsible for validation, PPAP, APQP packages to third‑party auditors.
• Understand statistics related to SPC, GR&R, MSA studies.
• Lead customer, internal and registrar quality system audits.

• Minimum 5 years (equivalent) experience in a product quality position, with direct experience in PPAP/validation deliverables. Experience in the medical device/life science (GxP) industry required.
• 4‑year engineering degree or substitute experience; graduate degree preferred.
• Ability to read blueprints and technical documents; understanding of ANSI/ISO drawing standards and GD&T dimensioning required.
• Familiarity with Minitab preferred.
• Knowledge of quality inspection tools and methods required; familiarity with SPC tools preferred.

• Knowledge of GMP/ISO/21 CFR 820 quality systems required.
• Knowledge of TQM, Six Sigma or Lean manufacturing principles preferable.
• Knowledge of progressive metal stamping and/or insert molding processes desirable.
• Strong technical writing skills.
• Proficiency in Microsoft Word, Excel, and PowerPoint.
• Knowledge of MRP or ERP software preferable.
• Excellent verbal and written communication skills.

This position is at our Fairfield, NJ location.

$100,000 – $110,000 per year

• Medical, dental, and vision
• 401(k) with company match
• Holiday, vacation, and sick time
• Tuition reimbursement
• Health Savings Account (HSA)
• Flexible Spending Account (FSA)
• Cigna Wellness Incentive Program
• Employee Assistance Program (EAP)
• Short‑term disability
• Group life and accidental insurance
• Sun Life – accident, critical illness, and hospital indemnity insurance
• Smoking cessation program
• Pet insurance

The base salary for this role will be determined on a case‑by‑case basis and may vary based on job‑related knowledge and skills, experience, and internal consistency.

Weiss-Aug is an Equal Opportunity/Affirmative Action Employer. Applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, protected veteran status, disability, or any other characteristics protected by applicable federal, state, or local law.