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Supplier Quality Engineer (Medical)

Kelly Services

Sunnyvale, CA
Job Code:
  • Engineering
Kelly Services
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Job Details

Job Title Supplier Quality Engineer (Medical)

Jobid US41L8AM_BH1432138

Location: Sunnyvale, CA, 94086, USA

Description A **Suppler Quality Engineering** job is available with Kelly Engineering Services in Sunnyvale, CA area. A Bachelor’s degree in engineering along with 5 years’ experience working in a manufacturing company, preferably a medical products company. You will perform day-to-day activities to support the manufacturing site, in relation to **Supplier Program** Requirements. Participates in the assessment of Suppliers through the Supplier Audit Program, assessing the Suppliers capability of meeting manufacturing standards and various regulatory standards, including ISO, FDA, cGMP, EU, PIC/S Maintains the approved Supplier List and supports new Supplier qualification activities. You will help set strategic direction for the quality organization and is responsible for designing and implementing methods and procedures for inspecting, testing, and evaluating purchased material.

Responsibilities include:

+ Participates in audits of Suppliers against appropriate global and regulatory requirements, provides written reports to auditees and management, and follows up on corrective actions.
+ Utilizes risk management tools and aids for use by the organization in accordance with documented procedures, including but not limited to **PFMEA, DFMEA, Fault Tree Analysis, Failure Mode Analysis, etc.**
+ Supports continuous product and process improvement through detailed failure analysis for non-conformances, and investigates, develops and implements effective and compliant solutions for product or process corrections, retrospective and remediation action plans, and for corrective and preventive actions **CAPA Program**
+ Lead component and process FMEA’s and Risk Assessments at suppliers.
Participate and/or lead supplier improvement programs.
Prepare and report supplier performance metrics.
Performs duties in compliance with environmental, health and safety related site rules, policies or governmental regulations.
+ Provides support for product investigations involving incoming commodities
Qualification Requirements:

+ B.S. Engineering degree or Science (Life Sciences, Physics, ME, EE, Industrial Technology, etc.)
+ 5-8 years related experience in the medical, pharmaceutical or health industry.
+ 5 years of vendor auditing experience preferred, preferably in Quality QA, QC, Regulatory Compliance, or Supplier Quality/Engineering. ASQ certification s preferred.
+ Demonstrated understanding or aptitude to understand **Medical Device QMS** requirements and regulatory requirements including but not limited to **FDA 21 CFR 820 and ISO 13485.**
+ Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies in-depth understanding of site level products related processes4.
**Why Kelly** **®** **?**

Kelly puts you in charge of your career, with access to cutting edge projects and technologies inindustry leading organizations. Top companies throughout the world have trusted Kelly as a premiersource of engineering talent and services since 1965. And engineering job seekers know Kelly as a firmwith an unmatched reputation for quality, integrity and professionalism. Whether you seek the varietyand flexibility of working on short term project engagements, or prefer contract-to-hire or directhire placement with our clients, apply with Kelly to explore opportunities that suit your specificprofessional interests.

**AboutKelly Services** **®**

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit and connect with us on Facebook, LinkedIn and Twitter .

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and iscommitted to employing a diverse workforce. Equal Employment Opportunityis The Law.

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