Quality Management Specialist

JOB OBJECTIVES:

 The Quality Management Specialist will be responsible for ensuring the quality and compliance of our medical devices, by implementing and maintaining Quality Management systems in accordance with ISO 13485 and MDSAP regulations. This role will work closely with the Quality/Regulatory Manager and other teams within the organization to ensure that all products meet the highest standards of quality and safety. This position is based in our headquarters in Walnut Creek, California.

 JOB DUTIES:

• Work with Engineering and Product Management teams to process Engineering Change Orders, Admin Change Orders, Temporary Deviations and Document Changes.
• Review and approve changes for accuracy, compliance, and completion.
• Provide training and guidance to internal team members on change procedure requirements, as needed. 
• Provide continuous improvement of Document Control processes and procedures in accordance with department and company goals.
• Write and help implement Corrective/Preventative Actions and Supplier Corrective Actions.
• Assist with Supplier Controls and audits.
• Assist with running and analyzing complaint metrics. 
• Maintain the annual calibration calendar.
• Assist Product Service team by closing out certain repairs, creating Certificate of Compliances and drafting customer letters. 
• Work closely with RA/QA to ensure regulatory and quality compliance of project deliverables, along with development of supporting documentation. 
• Create and maintain comprehensive and required project documentation as it pertains to the company’s Product Development System (PDS).
• Receive and distribute incoming orders for production components and prototype parts, as directed by Product Operations.
• Assist Product Management with control of documentation for active Arena Project Plans and maintenance of templates.
• Assist Engineering and Product Management teams with creation of engineering documentation in Arena (item numbers, file numbers, BOM development, artwork approvals, etc.). 
• Perform other duties as requested to support company quality and product development initiatives.

 REQUIREMENTS:  

 Minimum of 3 years of experience in a quality role in a medical device environment.

• Bachelor’s degree in a relevant field such as Engineering, Quality or Biology a plus.
• Strong knowledge of medical device regulations and standards, including ISO 13485 and FDA CFR. MDSAP, ANVISA and euMDR knowledge is a plus.
• Strong working knowledge of Adobe Acrobat, and MS Office.
• Ability to work in a high volume fast paced environment with minimal instruction on routine work, and general instructions on new assignments.
• Ability to work in a team environment and manage multiple tasks simultaneously with a disciplined approach for completing tasks on schedule.
• Excellent written and verbal communication skills.
• Possess strong organizational skills and attention to detail. 
• Proven ability to complete projects according to outlined scope, budget, timeline, and expectations.
• An ability to be flexible, adaptable, and work under pressure.

This job description is not exhaustive, and the role holder may be required to undertake additional duties or responsibilities as required.

REPORTS TO: Sr. Manager, Regulatory & Quality Affairs