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Description

Title: Quality Assurance, QA Specialist 3

Pay: BR

Hours: 8 - 5

How will you make an impact?

The role of the Quality Specialist is to support, strengthen and advance the Quality mission, which is enabling our customers to make the world healthier, cleaner and safer by continuously improving the quality of our products and services. The Quality Specialist will work with various team members and internal and external customers, with a high degree of professionalism. This is a very hands-on role and works collaboratively with other departments.

What will you do?

As a QA Specialist, you will help to ensure the Pleasanton site meets all the requirements for ISO 13485 and 21CFR820. You will partner with various Quality, Regulatory and Technical teams to address customer complaints.

• Write, review and process customer complaint investigations for medical device
• Collect relevant information from regulatory, technical and customer facing teams for investigation and complaint documentation
• Write and process customer complaint investigation in complaint system
• Help with final review and approval of complaint investigations

How will you get here?

Education

Bachelor s degree in life sciences, engineering, process engineering, chemistry, biotechnology or related sciences

Experience

• Experienced in documenting and processing complaints for medical device
• Experience working under ISO 13485, 21CFR820 (cGMP)
• 5+ years of work experience in Quality Assurance/Quality Systems role
• Experienced in using Trackwise (strongly preferred)
• Strong computer skills (Office, Teams, Word, Excel)
• Experienced with Quality tools and methodologies including investigation/root cause analysis

Knowledge, Skills, Abilities

• Must be self-motivated, proactive, organized, and detail oriented
• Strong analytical and problem-solving skills with attention to details and the ability to find creative solutions that meet regulatory and business requirements
• Solid organizational and time management skills to meet deadlines
• Highly energetic, positive attitude, and works well under stress
• Excellent communication and interpersonal skills with the ability to interact with all levels of the organization both orally and in writing
• Strong track record of working cross functionally