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Sr. Audit Supplier Quality Engineer

Company: Stryker Corporation
Location: Mahwah, NJ
Posted on: August 15, 2018

Job Description:

Senior Audit Supplier Quality Engineer for Stryker Corporation in Mahwah,

NJ to Review validation (IQ/OQ) documentation of suppliers to assess the

conformance of the supplier’s quality system with respect to Stryker’s

requirements and with respect to FDA 21 CFR part 820, ISO 13485 and ISO

9001 (10%). Review Gage R&R studies conducted by suppliers per Stryker

requirements (5%). Utilizing failure modes and effects analysis (FMEA),

process capability (Cpk, Ppk), and quality planning tools to determine

compliance with Stryker’s requirements (5%). Coordinate and implement on-site and engineering documentation audits, related corrective and preventive action (CAPA) and communicate evaluation results to key stakeholders (5%). Lead supplier quality audit for the Global Quality & Operations (GQ&O) audit program with respect to FDA 21 CFR Part 820, ISO13485 and/or ISO9001 to support the evaluation, selection, approval, and monitoring of suppliers and manufacturing partners (30%). Work with cross

site and engineering documentation audits, related corrective and

preventive action (CAPA) and communicate evaluation results to key

stakeholders (5%). Lead supplier quality audit for the Global Quality &

Operations (GQ&O) audit program with respect to FDA 21 CFR Part 820,

ISO13485 and/or ISO9001 to support the evaluation, selection, approval, and

monitoring of suppliers and manufacturing partners (30%). Work with cross-divisional and cross

divisional and cross-functional engineering component suppliers, contract

manufacturers, and original equipment manufacturers to drive process

improvements of the quality systems (20%). Act as an engineering liaison

between Suppliers, Purchasing, and Manufacturing, to support projects and

to resolve divisional and site engineering quality issues (10%). Serve as

an engineering subject matter expert for supplier evaluations (5%). Ensure

purchased components, sub-assemblies, and devices comply with engineering p

print specifications and applicable regulations (5%). Supply information i

into the metrics, trends, and performance indicators of suppliers to drive c

continuous improvement throughout the supply chain (5%).

Telecommuting position - must live within a commutable distance of Mahwah,

New Jersey. Requires: Bachelor's degree in Biomedical Engineering,

Bioengineering, Biotechnology, Mechanical Engineering or Electrical

Engineering (willing to accept foreign education equivalent) plus five (5)

years of experience performing quality engineering in the medical device

industry or, alternatively, a Master's degree and three years of experience

as noted above. Specific skills/other requirements (quantitative experience

requirements not applicable to this section): working with Quality

Management System and conducting internal or external audits with respect

to FDA 21 CFR Part 820, ISO13485 and/or ISO9001 (3+ years); authoring,

reviewing or evaluating, and design verification for equipment

qualification (IQ/OQ) using risk analysis and Statistical Process Control

(SPC) procedures (3+ years); utilizing failure modes and effects analysis

(FMEA), process capability (Cpk, Ppk), and quality planning tools to

determine compliance with company requirements (3+ years); conducting

measurement system analysis (MSA) or Gage R&R activities to evaluate

equipment qualification status; validation program implementation for ISO

certification; and reviewing and evaluating Computer Aided Design (CAD) and

stack-ups for mechanical prints. Submit resume to Stryker Corporation,

Nicole K. Benn, 1901 Romence Road Parkway, Portage, Michigan 49002.

Reference Position Number: 179.

Keywords: Stryker Corporation, Elizabeth , Sr. Audit Supplier Quality Engineer, Manufacturing , Mahwah, NJ, New Jersey

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