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ER79 - Quality Manager

Kelly Services

San Jose, CA 95115
Kelly Services
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Job Details

**Quality Manager -**

An exciting opportunity has arisen for a Quality Manager in our San Jose plant, who will be responsible for the effectiveness of the Quality Management System (QMS) and driving improvements in quality at the site. This includes maintaining and improving the effectiveness of the processes required in the manufacturing of our Nitinol medical components. Developing and enhancing focused relationships with our global customers is an imperative.

**Key responsibilities**

Manage the continued effectiveness of the ISO 9001 certified QMS and report status to the Head of Quality, the San Jose Site Operations Manager and other members of senior management. Ensure all applicable elements of the QMS are performed accurately, effectively and timely.

As the main quality liaison for the site, professionally lead all communication exchanges with external parties, including QMS certification, registrar audits, customer audits, customer surveys, customer investigations, etc.

Ensure adequate and effective process control and verification of all stages of manufacture to assure all products meet all customer, Co and regulatory requirements.

Manage all quality laboratories and ensure equipment calibration and servicing processes are effective.

Coordinate resolution of product and process quality issues using structured problem-solving methods. Analyse non-conformances to establish root causes and effect corrective action.

Apply quality engineering and improvement tools to optimize processes and support all process development aspects for new products, processes and equipment.

Co-ordinate new equipment validation using installation qualification, operation qualification and performance qualification systems.

Manage supplier quality performance and assess capability for manufacturing and quality systems in conjunction with purchasing and engineering.

Ensure that all operating procedures, manuals and other controlled work instructions are properly prepared, reviewed, approved, controlled, implemented, and amended, as required.

Develop and champion site wide quality improvement plan, based on both customer and internal data.

Be deployment champion for problem solving and quality methods, building proficiency within the site.

Comply with all companies procedures and local, state and federal regulatory requirements.

+ Strictly follow all equipment installation, operation, and maintenance safety protocols.

**Are you the ideal candidate?**

The position requires a Bachelors degree in engineering with 5-10 years supervisory/management experience and 5 years experience in being responsible for an ISO 9001-compliant Quality Management System. The Incumbent must possess excellent communications skills, both oral and written. The ability to motivate and work well with others will be essential. Significant experience of ISO 13485 is highly desired, or alternatively detailed experience in leading QMS to automotive or aerospace standards would be considered. The ability to work with, and statistically analyze, data will be required, with Six Sigma Green/Black Belt certification being desired. Proficiency in computing, including MS Office and data analysis tools will be required.

**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.

**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 is
committed to employing a diverse workforce. Equal Employment Opportunity
is The Law.
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