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, Bayonne , Sr. Audit Supplier Quality Engineer, Manufacturing , Mahwah, NJ, New Jersey
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