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Product Quality Engineer

Location : Caldwell NJ US 07006
Job Type : Direct
Reference Code : 20668-AS1
Compensation : 85000.00 - 95000.00 USD/YEAR
Start Date : 08/12/2021
Hours : Full Time
Required Years of Experience : 5
Required Education : BS Engineering
Travel : No
Relocation : No
Job Industry : Medical Devices

Job Description :

  • Permanent position for a Product Quality Engineer for medical device manufacturing.

  • Responsible for Validation and PPAP packages on new customer programs, as well as ensuring compliance with applicable regulatory bodies and standards (ISO13485, 21 CFR 820, GMP).

  • Responsible for technical writing for FDA and regulatory submissions.

  • Responsible for data analysis using Minitab based on SPC, GR&R, and MSA Studies.

  • Ensure 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 such as 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 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.

  • Responsible for SOP and Technical Writing for New Programs.

  • Responsible for Master Validation Reports, including writing and execution of IQ, OQ, PQ Protocols.

  • Participate in customer, internal and registrar quality system audits.

Required Qualifications :

  • BS Engineering, advanced degree preferred.

  • Minimum 5 years experience in product quality position, with direct experience in quality system compliance.

  • Experience in medical device/life science (GxP) industry required.

  • Ability to read blueprints and other technical documents. Understanding of ANSI/ISO drawing standards and GD&T dimensioning required.

  • Ability to use SolidWorks for product/tooling design preferable.

  • Ability to use 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.

  • Exceptional analytical and computational skills.

  • Knowledge of problem-solving tools and techniques preferred.

  • Excellent verbal and written communication skills.

  • Demonstrated high level of creativity and innovation.

  • Demonstrated decision-making capability.

  • Must have practical knowledge of GMP, ISO13485, and/or 21 CFR 820 Compliance.

  • Ability to understand statistics as related to SPC, GR&R, MSA Studies.

Contact: Alex Salewycz

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