Compliance Specialist - Medical Device at Varex lmaging
Posted in Compliance 30+ days ago.
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Type: Full Time
Location: Salt Lake City, Utah
Varex Imaging is looking for a COMPLIANCE SPECIALIST oversees the site s Quality System and ensures it is adequately maintained out of our Salt Lake City, Utah facility.
IN ADDITION, THE COMPLIANCE SPECIALIST:
* May need to work on alignment with Corporate Quality System and/or other sites Quality Systems.
* Responsible for coordination and performance of internal and external audits.
* Ensures compliance with relevant regulations (e.g. FDA 21 CFR 820) and standards (e.g. ISO 13485).
* Collaborates with customers and regulatory authorities to develop positive and proactive approaches to regulatory compliance.
* Participates in good manufacturing practices, supports production operations and training of functional areas.
* Ensures adequate Document Control is practiced.
* May coordinate activities and assist with interactions during regulatory agency inspections.
* May direct interaction with regulatory agencies on defined matters.
* Recommends strategies for ensuring compliance to changes of applicable medical device regulatory standards.
* Oversees the analysis of quality data and facilitates the creation and implementation of corrective and preventive actions (CAPA).
* Works closely with Corporate Office updating Corp. on current Quality System status and maintaining compliance at satellite sites.
MINIMUM REQUIRED SKILLS & KNOWLEDGE:
* Bachelor s Degree or equivalent experience.
* 2-5 years of related experience in medical device regulated industry
* Familiarity with relevant regulations and standards (e.g. 21 CFR 820, ISO 13485 and ISO 14971)
TIME TYPE:Full time
PAY RATE TYPE:Salary
All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.