CenterWatch

1+ months

Complaint & Compliance Auditor

Kelly Services
South San Francisco, CA 94080
**Title:** Complaint/Compliance Auditor





**Location:** South San Francisco



**Salary:** $100,000 - $110,000/year





**SUMMARY:**



Under the direction of Technical Support Management is responsible for review and enforcement of the complaint and compliance standards or regulations required by ISO 13485 and FDA regulations (21 CFR 820), and Tosoh Bioscience, Inc. (TBI) Policies and Procedures.





**ESSENTIAL DUTIES AND RESPONSIBILITIES:**




+ Knowledge, experience and expertise of the applicable regulations, standards and guidance documents including 21 CFR Part 820.198, 803 and 806; ISO13485:2016. MDSAP Complaint/MDR audit Requirements nice to have.

+ Possession of the knowledge and skills necessary to achieve the intended results of the complaint/MDR audits they are expected to perform.

+ Complaint/MDR auditors shall also be able to:

+ Apply complaint/MDR audit principles, procedures, and methods

+ Demonstrated organizational skills with strong attention to detail

+ Conduct the complaint/MDR audit within the agreed time schedule;

+ Prioritize and focus on matters of significance;

+ Collect information through effective interviewing, listening, observing and reviewing documents, records and data;

+ Understand and consider the subject matter experts opinions

+ Understand the appropriateness and consequences of using sampling techniques for complaint/MDR auditing;

+ Verify the relevance and accuracy of collected information

+ Confirm the sufficiency and appropriateness of complaint/MDR audit evidence to support complaint/MDR audit findings and conclusions;

+ Assess those factors that may affect the reliability of the complaint/MDR audit findings and conclusions;

+ Use work documents to record complaint/MDR audit activities

+ Document complaint/MDR audit findings and prepare appropriate complaint/MDR audit reports;

+ Maintain the confidentiality and security of information, data, documents and records

+ Conduct meetings with the other technical managers to discuss complaint handling trends to keep improving the process

+ Demonstrated ability to effectively interface and communicate with multiple constituents

+ Possess strong written, verbal and presentation skills to all levels of an organization

+ Ability to make decisions and execute directives

+ Ability to work under tight deadlines and handle multiple detail-oriented projects

+ Proficient with MS office programs (Word, Excel, PowerPoint, Project)

+ Submit MDRs and Recall advisories according to FDA requirements and ensure that all follow-up activities are completed and are communicated to manufacturer as required

+ Complete required registration and reports as required by Federal Regulations

+ Participate in FDA Inspections as required





**QUALIFICATIONS:**




+ Bachelor Degree in a biological or Health science-related field.

+ An in-depth understanding of FDA regulations (21 CFR Part 820.198, 803 and 806) is required:






**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: 2019-09-27 Expires: 2019-11-28

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Complaint & Compliance Auditor

Kelly Services
South San Francisco, CA 94080

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