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Quality Assurance (QA) Coordinator

Kelly Services

San Diego, CA
Job Code:
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Job Details

Job Title Quality Assurance (QA) Coordinator

Jobid US15TPAF_BH1427381

Location: San Diego, CA, 92108, USA

Description **Quality Assurance (QA) Coordinator, San Diego, CA**

**Job Summary:** To ensure compliance to FDA, ISO and various regulatory requirements through management of Deviations, non-conformances, Quality System audits and CAPA system.

Responsibilities are to be carried out in accordance with established procedures, policies and applicable regulations / standards.

**Pay Range:** $18-22/hr

**Essential Duties and Responsibilities:**

+ Work with company personnel to assure compliance to the Quality System Regulations, ISO 13485, Canadian Medical Device Regulations and other applicable local, State, Federal or international regulatory requirements.
+ Oversees and manages day to day activities of the internal quality audit system.

+ Coordinate internal audit logistics as per approved schedule.

+ Follow up to ensure that corrective actions are performed for audit findings.
+ Participate in audits of the Quality System by regulatory bodies, ISO or Suppliers.

+ Responsible for the corrective action process following second or third party audits/

+ Prepare or assist with responses to external audits.
+ Oversees and manages the CAPA system for timeliness and compliance.

+ Review issues, recommend CAPA, review investigation reports, monitor effectiveness verification checks and ensure CAPAs are closed in a timely manner.

+ Oversee the CAPA Review Board.
+ Oversees and manages the non-conformances process.

+ Ensure that NCRs are reviewed and completed in a timely and compliant manner.

+ Host and/or participate in the Materials Review Board
+ Oversees and manages the Deviation process.

+ Ensure that Deviations are reviewed and completed in a timely and compliant manner.
+ Trends, analyzes and reports on quality data derived from internal/external audits, nonconforming product, CAPA, Deviations, and other sources; develops recommendations based on data analysis. Presents data as needed.
+ Support Management Review process.
+ Responsible for providing Quality classroom training for new hires.
+ Responsible for promoting safety awareness, providing ongoing task-specific safety training and monitoring compliance with applicable safety regulations for direct reports. Interact as needed with the Manager, Environmental, Health and Safety to obtain information and/or support in order to minimize work-related accidents, injuries and near misses in area(s) of responsibility.
+ Other duties may be assigned.
**Job Requirements:**

+ At least two (2) years' experience with Quality Systems - documentation and coordination efforts.
+ Familiar with CAPA and ISO and regulations.
+ Possessing strong attention to detail
**Why Kelly** **®** **?**

With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevantprojects. Our connections can lead you to innovative scientific pursuits you’ll be proud to helpadvance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the worlda better place. Let Kelly fuel your career—connect with us today.

**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 connectwith 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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