Job Type
Full-time
Description
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 (ISO13485, 21 CFR 820, GMP).
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 management 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.
This position is at our
Fairfield, NJ location.
Pay Range: $100,000 - $110,000 per year
Other Benefits Include- 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
US Pay Transparency The base salary for this role will be determined on a case-by-case basis and may vary based on the following considerations: job-related knowledge and skills, experience, and internal consistency.
If your salary requirements exceed the advertised range and you remain interested in Weiss-Aug, we encourage you to apply.
