Quality Operations Specialist needed for a contract opportunity with our client located in Irvine, CA.
What You Will Be Doing:
- Review and investigate assigned technical and clinical customer complaints. Perform technical investigations and document results per established procedures and timelines.
- Supports quality functions pertaining to manufacturing line support and maintenance, including SAP.
- Performs hands-on troubleshooting of customer returned devices and manufacturing nonconformities and completes associated technical documentation
- Assist complaint intake group through review and verification of initial complaint coding
What You Need to Bring to the Table:
- Bachelor’s Degree
- Years’ Experience: 2-5 years
- Familiarity with regulatory reporting requirements for medical devices (e.g. MDRs, Vigilance reports, etc);
- Familiarity with medical device complaint files and quality records;
- Knowledgeable of FDA regulations, 21 CFR part 820 and Part 803 and ISO 13485 standard;
- Strong computer skills (including Excel)
- Demonstrated written and verbal communication skills
Recruiter: Stephanie Leahey firstname.lastname@example.org
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Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Visit https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process.
Location/Region: Irvine, California