Validation Engineer

Be part of a company that’s shaping the future of manufacturing where your ideas, skills, and passion matter.

Full-time

Be part of a company that’s shaping the future of manufacturing where your ideas, skills, and passion matter.

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.

At Weiss-Aug we are driven by a commitment to excellence, innovation, and continuous improvement. As a recognized leader in the industrial and commercial sectors, specializing in high-volume metal stamping, thermoplastic molding, and value-added assembly solutions our Weiss-Aug Med Pharma serves the medical device and life science industry, offering unparalleled vertically integrated manufacturing solutions, partnered with in-house product design and engineering services.

These combined capabilities provide

Weiss-Aug a strategic advantage over the competition, being able to offer our customers a true, single-source supplier option, to meet their most challenging product innovation needs.

As we continue to push the boundaries of what is possible, including our latest advancements in materials science, specialty coatings, laser processing, and hybrid additive manufacturing technologies – Weiss-Aug Med Pharma needs the best minds in industry. Expanding our team is paramount, bringing in fresh perspectives, ideas and broad-based talent to further enhance our solution offerings, driving new growth and supporting our technology roadmap – including the release of 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 to our customers worldwide. In this role you will be responsible for Validation/PPAP Packages on new customer programs, as well as ensuring compliance is applicable regulatory bodies and standards (ISO
13485, 21 CFR 820, GMP).

• 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, ISO
  13485, 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.

• Minimum of 5 yrs. (equivalent) experience in product quality position, with direct experience PPAP/Validation Deliverables. Experience in medical…