Quality Engineer Westpak, Inc. - San Jose, CA

 Are you passionate and determined, creative & open-minded?  Do you build open & honest relationships with communication?  Can you always be counted on to go beyond excellent customer service whether internally or externally focused?  Do you actively pursue growth, learning, & understanding?  Would others say you act with integrity and accountability?  Do you value wisdom and embrace change?  Are you humble and do you seek the truth always? Westpak's mission is to provide the best possible and highest quality testing services in an environmentally friendly manner, using calibrated and well-maintained equipment at all times, conducted by test engineers that are knowledgeable, highly motivated, and well-trained.

A Quality Systems Engineer candidate will:  Support the maintenance of quality system requirements, including: CAPA system, external, internal and supplier audits, quality metrics reporting, management review preparation, and training  Facilitate and drive proactive problem solving techniques for effective root cause analysis and successful corrective action.  Develop and Drive the training component in the Quality Management System. This includes implementing and conducting training, effective training system management, and  Recommend and implement enhancements to the quality system that result in improved corporate quality performance, increased customer satisfaction, and/or simplification of processes to reduce costs.  Perform in-depth audits of Quality System Element against internal and external requirements including regulatory requirements, industry standards, regulatory guidance documents, corporate policies and standard operating procedures, and local procedures, documents, and records  Prepare well written and clear audit reports and related audit observations and findings or opportunities for improvement in a structured format using excellent writing skills  Support the preparation and issuance of the annual internal audit schedule including related documentation in accordance with internal audit policies and procedures  Coordinate and direct external 3rd party registration/surveillance audits  Oversee the controlled document system, in accordance with standard quality certification requirements.  Establish and update quality system procedures in compliance with requirements for medical devices  Prepare metrics in support of operational needs, management review, and any other quality driven data.  Demonstrates excellent working knowledge of the QMS, handles NCRs, CAR’s, and PAR’s  Solving problems and facilitating efforts to implement preventative and corrective actions.  10% travel required to support the business needs.  The above statements are intended to describe the general nature and level of the work being performed by the employee assigned to this position. There are no exhaustive lists of all duties and responsibilities, knowledge, skills, abilities, physical job demands and working conditions associated with this position. Personal / Professional Attributes  Strong business acumen and functional linkage for effectiveness  High focus on customer service, and willing to go above and beyond to get the job done.  Drives leadership and accountability  Work collaboratively with colleagues  Strong ethical composition  Ability to fine innovative solutions to complex problems.  It is the responsibility of every Westpak employee to contribute to a positive work environment through cooperative and professional interactions with co-workers, customers, and vendors. Requirements for Eligibility  Bachelor's degree (B.S.) in Quality, sciences or related field  5-7 years of experience operating in a robust Quality Management System as QS/QM/QA/QC role, prior medical device environment preferred.  Previous work experience in ISO13485 and ISO17025 is preferred.  Verification and Validation techniques(IQ,OQ,PQ) and methods  Have experience working on product development teams following Design Controls and Risk Management processes  Previous internal or supplier auditor preferred.  Experience with statistical analysis of quality data  Working knowledge structured problem solving methodology(Kepner-Tregoe, 8d, Shainin, 5 Why, DEMAIC, Kaizen, Lean Six Sigma) and quality tools (Cause and effect/Ishikawa-Fishbone, Control Charts, PDCA, Pareto Analysis, Check Sheet)  Previous experience managing and supporting an integrated QMS Training material to support QMS and organizational needs.  MS Word, Excel, PowerPoint proficient, MS Access or similar relational database proficiency is preferred.  Software validation experience a plus  Direct experience managing or participating in an FDA and other agency audits a plus