Kelly Services Compliance Specialist / Recall Coordinator, Westlake Village/Thousand Oaks, CA in Westlake Village, California
Quality Compliance Specialist / Recall Coordinator, Westlake Village / Thousand Oaks, CA
As a Compliance Specialist / Recall Coordinator, your responsibilities include application of relevant US and International Laws and Regulations to major compliance activities. Examples include interpretation and application of Recall Regulations found in 21 CFR Parts 7, 806 and 810. Responsible for leading cross-functional teams in conduct of Health Hazard Evaluations and Recalls. Responsible for all maintaining major compliance initiatives including ensuring compliance with ISO 13485, GUDID (Global Unique Device Identification Database) Prepare reports and coordinates activities as requested. Responsible back-up for the Document Control Specialist and RA Supervisor. This position has growth potential within the compliance department.
Pay Range: Open depending on experience
Position Type: Contract, project need. Potential for full-time hire.
Essential Duties and Responsibilities:
Will be notified of any potential recall event and will need to schedule meetings, scribe, fill out necessary forms, and if necessary, coordinate recall notification letters.
Recall activities include:
Schedule and lead meetings
Oversee Recall execution, closure and documentation
Maintain and complete all entries in the GUDID.
Assist via conducting MDR evaluations
Assist via review, and coordinating offsite scanning and storage for completed job order packets.
Support Training Compliance efforts
Development and or revise procedures.
College degree and two (2) years of relevant experience preferred.
Ability to read and write reports and company procedures.
Ability to apply common sense understanding to carry out detailed written and/or oral instructions. Being able to quickly assess large amounts of information and data. The ability to consider and evaluate the interrelationships of numerous factors and to select the best course of action is imperative. In the absence of sufficient information, sound intuitive judgment is crucial to reaching favorable decisions.
Strong organizational skills.
Ability to read, understand and retain extensive working knowledge of procedures and company documents.
Must be extremely detail-oriented, and able to work in a fast-paced environment.
Strong Microsoft Office applications.
Ability to carry out detailed, written or oral instructions.
Knowledge of computer files management software. QCBD preferred.
Able to produce positive results with a strong sense of urgency. Knowledge of US and International (CAN, EU) Medical Device Regulations (e.g. Quality System Requirements and Standards and ISO 13485).
For immediate consideration, apply today! Questions? Call Jason at 714.971.0721
Why Kelly ® ?
With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 11,000 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 career—connect with us today.
AboutKelly Services ®
As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2016 was $5.3 billion. Visit kellyservices.com and connect with us on Facebook , LinkedIn and Twitter .
Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm