Validation Engineer

Join Weiss-Aug – A Leader in Precision Manufacturing and Innovation

About the role

Weiss-Aug, a leading provider of advanced manufacturing and engineering solutions, seeks a passionate and skilled Validation Engineer to join our team. This role contributes to our mission of delivering high-quality, engineered solutions to our customers worldwide.

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 manage 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.

Requirements

• 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.
• Ability to uses Minitab preferred.
• Knowledge of quality inspection tools and methods required. Familiarity with Statistical Process Control (SPC) tools and methods also preferable.
• 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.
• Proficient in Microsoft Word, Excel, and PowerPoint.
• Knowledge or MRP or ERP software preferable.
• Excellent verbal and written communication skills.

Qualifications

• 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.
• Ability to uses Minitab preferred.
• Knowledge of quality inspection tools and methods required. Familiarity with Statistical Process Control (SPC) tools and methods also preferable.
• 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.
• Proficient in Microsoft Word, Excel, and PowerPoint.
• Knowledge or MRP or ERP software preferable.
• Excellent verbal and written communication skills.

Benefits

• 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, and Hospital Indemnity Insurance
• Smoking Cessation Program
• Pet Insurance