Supplier Quality Engineer I - Biomaterials

Cartwright James
US$60k - US$80k pa + Full package and bonus
19 Oct 2016
17 Nov 2016
Contract Type
Supplier Quality Engineer I

Job description
Position Duties & Responsibilities

The Supplier Quality Engineer will conduct audits to good manufacturing practices, international organization for standardization and any other applicable standards. He/she will provide complex product team support for quality system design and audit, compliance assessment, and for support of steady state manufacturing processes. This individual will utilize multifaceted industry and process excellence standards in daily quality operations, including good manufacturing practices (GMP), equipment engineering system (EES), and international organization for standardization (ISO).
*The Supplier Quality Engineer will address and correct product and process complaints.
*He/she will report on contract manufacturer performance metrics and management reviews.
*This individual will oversee audits of all quality system categories to assess compliance to process excellence standards.
*The Supplier Quality Engineer will ensure comprehensive measurement systems to monitor effectiveness of quality and reliability systems to identify, bracket, correct and prevent defects, presenting reports to management.
*He/she will handle technical issues for manufacturing processes that are to be transferred to satellite facilities.
*This individual will provide Quality Engineering support to suppliers including audits/assessments, inspection technique support, verification/validation activities, CAPA and change management.
*FDA CFR Part 820 and ISO 13485 regulations/standards will be the focus.


*A minimum of a Bachelor's Degree is required. A Degree in Engineering, Life Science, or related discipline is preferred.
*A minimum of 2 years of experience in a GMP and/or ISO regulated industry is required.
*Experience in the medical device and/or pharmaceutical industry is preferred.
*Both, FDA and ISO regulations knowledge is preferred. FDA CFR Part 820 and/or ISO 13485 knowledge is preferred.
*Demonstrated expertise with statistics, sampling strategies, design of experiments, and structured problem solving methodologies is preferred.
*Strong communication, teamwork, and problem solving skills are required. Prior experience working collaboratively in a highly matrixed organization is preferred. Intermediate knowledge and use of Microsoft office are required.
*Experience in auditing is preferred.
*An ASQ certification (CQE, CQM, CRE or CQA) is preferred. Six Sigma (Green Belt, Black Belt, etc.) or Process Excellence certification is preferred. Excellent Investigative skills such as analytical problem solving, Fishbone/Ishikawa, root cause analysis, etc. are an asset.