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27 days old

Quality Engineer - Risk Management (Medical Devices / IVDs), San Diego, CA

Kelly Services
San Diego, CA 92108
**Quality Engineer - Risk Management, San Diego, CA**



**Position Summary:** Provides technical expertise and recommendations for the risk management system to ensure compliance with regulatory and internal requirements. Position is responsible for facilitating the development and completion of product and process risk assessments.



**Essential Duties and Responsibilities:**




+ Collaborates with Sr. Leadership to develop a risk management program

+ Implements and maintains a risk management process in the Quality System that conforms with ISO14971 across product realization for company's commercialized products.

+ Develops and maintains risk management files in accordance with medical device industry regulations and internal requirements, including all development and post-market requirements.

+ Conducts risk assessments and creates or revises risk management documents, in accordance with Standard Operating Procedure (SOPs), FDA, EU and other medical device regulations.

+ Collaborates with various company departments and teams to create and maintain risk management records compliant with International Standard ISO14971 and company procedures.

+ Works with product development, manufacturing and support teams to assess risk and provide feedback regarding design-related and user-related failures.

+ Partners with the system owner and users to drive continuous improvement for an effective risk management system.

+ Defines best practices to aid in the implementation of risk management requirements

+ Provides training to product teams regarding risk identification assessment, control and communication.

+ Prepares and presents reports, based on risk related data, trends and KPIs.

+ Leads and participates in a variety of projects to reduce risk and improve processes and product.

+ Supports audits related to product risk management.

+ Complies with applicable company standard operating procedures (SOPs), ISO 13485, FDA 21 CFR and other applicable Quality System regulations, as well as applicable Environmental Health & Safety, Human Resources and other regulatory and administrative policies.

+ Reflects company values in the quality of work and in working relationships.



**Job Requirements:**




+ Bachelor's degree required, preferably in life sciences or biomedical engineering.

+ 5+ years of applicable experience, preferably in risk management of medical device / IVD

+ Experience in product safety risk management in research / engineering, new product development, operations, and/or complaint handling required.

+ Experience with risk management (ISO 14971) required. Experience should include work with regulations and standards related to medical devices / IVD as it relates to product design, development and testing.

+ Demonstrated experience facilitating and collaborating within cross functional teams required.

+ Demonstrated experience writing and/or interpreting documents such as safety rules, complex operating and maintenance instructions, SOPs and house specifications.

+ Experience with internal and external regulatory audits strongly preferred.



**For immediate consideration, apply today! Questions? Email jason.ines@kellyscientific.com**






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



With Kelly, youll have access to some of the worlds highest regarded scientific organizationsproviding you with opportunities to work on todays most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits youll be proud to help advance. We work with 90 of the Fortune 100 companies and found opportunities for more than 10,000 scientific professionals last year.


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




**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. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm
Posted: 2019-10-18 Expires: 2019-11-18

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Quality Engineer - Risk Management (Medical Devices / IVDs), San Diego, CA

Kelly Services
San Diego, CA 92108

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