Validation Engineer

Weiss-Aug MedPharma; Fairfield (NJ); Sur place; USD 100 000 - 110 000; Plein temps

Avantages offerts par ce poste

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)

Résumé du poste

Weiss-Aug MedPharma in Fairfield, NJ seeks a Validation Engineer to lead PPAP/Validation deliverables, IQ/OQ/PQ, and APQP packaging to ensure GMP/ISO13485 and 21 CFR 820 compliance for medical device programs.

You will author SOPs, coordinate change controls (ECO), and participate in R&D design reviews with a focus on key quality deliverables and customer satisfaction.

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.

Responsabilités

• 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.

Connaissances

PPAP/Validation

GxP knowledge

Minitab

Technical writing

Microsoft Office

GD&T

Formation

Four-year engineering degree

Outils

MRP/ERP software

MS Office

Description du poste

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.

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.

Why Join Us?

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 MedPharma 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 MedPharma 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 (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.

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.