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30 days old

Supplier Quality Engineer

Kelly Services
Milpitas, CA 95035
**The Senior Supplier Quality Engineer**



**Long-term contract**



**Pay $60 per hour**



**As a Kelly Services Project Services employee, you will have access to numerous perks, including:**




+ **Vacation and sick pay**

+ **Paid holidays**

+ **401(k) plan**

+ **Group medical, vision, dental, life, and short-term disability insurance options**

+ **Kelly Discounts on goods and services, auto and home insurance, and tuition at Kelly partner schools**

+ **Kelly Learning Center offers free courses and trainings**

+ **Weekly pay**



The Senior Supplier Quality Engineer provides overall quality assurance leadership, serving as supplier-related QA technical and compliance lead for pre- and on- market product by ensuring the outsourced activity and associated product is qualified for use by the business unit.



Key areas of focus within supplier management are leading supplier & process qualifications, leading issue/defect resolution, managing performance monitoring/reporting, compliance to standards, and stream lining processes.



Key areas of support provided to team members include; risk management/ communication, defect resolution, process capability/process improvement, and quality assurance general support.



Adheres to environmental policy, procedures, and supports department environmental objectives.



**Main areas of responsibility**




+ Actively participate on cross-functional team projects in a structured business environment in accordance with internal procedures and external regulations

+ Participate in local site supplier/EM quality meetings to ensure communication and alignment of quality initiatives/objectives. Support internal and/or external cross-functional and cross sector project teams driving supplier/EM improvement and general initiatives through reducing variations in supply chain, institute control plans, and improving process capability.

+ Facilitate supplier quality system audits and associated actions

+ Provide internal and third-party inspection support. Accountable, as applicable, for compliance in accordance with regulations such as and from, but not limited to, FDA 21 CFR 820, ISO 13485, EU MD Directive/Regulations, Japan PAL, Canada CMDCAS, Brazilian ANVISA, and Australian TGA for assigned products.

+ Support internal and lead supplier root cause investigations and corrective actions. Lead defect resolution, root cause investigation, and continuous improvement activities. Collaborate across functions to confirm if non-conformances are supplier/EM related as applicable.

+ Monitor and report supplier and internal performance & quality metrics and support product/process improvements

+ Support product development by ensuring suitability of internally-developed specifications, instructions and test methods and leading the design transfer to the supplier, including providing QA technical and compliance expertise for risk analysis/assessments and process/test method validations



**Main areas of responsibility in addition to the items listed above**




+ Participate in decisions that are aligned with management objectives regarding work processes, plans and schedules in order to achieve department objectives

+ Tracks and reports progress across projects and departmental commitments by reviewing schedules and due dates, identifying risks, and assisting teams with contingency plans

+ Monitors compliance with company policies, procedures and applicable regulatory requirements



**Qualifications**




+ A Bachelor's Degree in Engineering, Electrical, Mechanical or Industrial or related science/technical field or an equivalent is preferred.

+ Previous Quality or Manufacturing Engineering experience

+ 5 years experience in an FDA regulated industry (Biotech, Pharma or Medical Device manufacturing) is required

+ Basic understanding of the Medical Device Quality Systems is required

+ Working knowledge of Word, Power Point and Excel with competency in moderately complex functions for data analysis and trending is required

+ Experience in the Medical Device industry is preferred. Experience in the Pharmaceutical industry or Electrical, Mechanical, Chemical, Packaging, Plastics or other manufacturing industry is preferred.

+ Basic understanding of FDA and ISO regulations is preferred. Experience with 21 CFR 820; 21 CFR 210/211; ISO 13485; ISO 9001; Canadian CMDCAS; Japanese PAL; Brazil ANVISA, Australian TGA, and EU MDR is preferred.



Additional Position Requirements Up to 30% travel, Full Time with weekday business hours (all local travel).




**Why Kelly** **** **?**



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




**About Kelly** ****



At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.

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Posted: 2019-10-18 Expires: 2019-11-28

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Supplier Quality Engineer

Kelly Services
Milpitas, CA 95035

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