Quality Engineer/Product Quality Specialist

Quality Engineer/ Product Quality Specialist

Product Quality Specialist must have at least 5 yrs. experience in the medical device, or other FDA regulated industry. Position is 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). Position requires heavy technical writing skills, attention to detail, and engineering knowledge. Ability to understanding statistics as applied to quality principals is needed (SPC, GR&R, MSA Studies), and strong background using Minitab software preferred.

POSITION FUNCTIONS

• Represent the customer 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.
• Responsible for SOP and Technical Writing for New Programs
• Responsible for Master Validation Reports, including writing and execution of IQ, OQ, PQ Protocols
• 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

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

KNOWLEDGE/SKILLS/EXPERIENCE REQUIRED

• Minimum of 5 yrs. experience in product quality position, with direct experience in quality system compliance. 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 use SolidWorks for product/tooling design preferable.
• 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.
• Exceptional analytical and computational skills. Knowledge of problem-solving tools and techniques preferable.
• Excellent verbal and written communication skills.
• Demonstrated high level of creativity and innovation.

• Demonstrated decision-making capability

No sponsorship visa (H1-B, etc) candidates at this time, sorry.


Qualified candidates must submit their resume in Microsoft Word format along with at least three professional references to:


COYOTE TECHNICAL & EXECUTIVE SOURCING
Phil Montoya
Director of Sourcing

Product Quality Specialist (Essex county NJ)

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