Recall Coordinator
Recall Coordinator
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1 Vacancy
Job Description
Changing lives. Building Careers.
Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us change equals opportunity. Every day our colleagues are challenging whats possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.
The Recall Coordinator - works cross functionally to complete Health Hazard Evaluation (HHE) presents to senior leadership for actions to be taken in the field. If action is necessary - coordinates and completes field actions. Initiate HHEs and maintain the corporate working and completed HHE archive files
Participate in and where appropriate lead team meetings and activities where
investigation findings and HHEs are discussed and developed to the point of approval.
Assure HHE documentation is complete accurate and addresses regulatory
requirements prior to approval.
Provide approved HHEs to the Field Action Committee (FAC) and resolve any questions/
comments
Continually monitor and provide routine reports to management on the progress to
completion of HHEs.
Coordinate and where appropriate lead team meetings and activities to complete the
documentation needed to initiate global corrections and removals.
In conjunction with other global QA & RA functions prepare documented recall
strategies for review and approval.
Ensure corporate working and completed correction/ removal files are maintained and
archived.
When needed to increase recall effectiveness develop and use alternate methods to
identify and contact customers affected by a recall.
Prepare correction / removal status updates to US regulatory authorities and submit on
a timely basis.
Prepare correction / removal close-out reports to US regulatory authorities for internal
review and submit after approval
Continually monitor and provide routine reports to management on the progress to
completion of corrections/ removals.
Provide support and / or participates in regulatory audits/inspections as required.
Maintain identify topics participate in and as needed prepare materials for integras
Safety Board
Write and or revise department procedures as needed.
Keep apprised of new regulations standards policies and guidance documents issued
by relevant regulatory authorities that may impact HHEs corrections and removals.
Performs all other related duties as directed by management.
Qualifications:
5 -7 years experience in a medical device or pharmaceutical company responsible for
administration of quality engineering activities specifically those related to the
assessment of risk and recalls
ASQ Quality Engineer and/ or Regulatory Affairs Certified (CE/ RAC) preferred
Computer skills to include knowledge and proficiency with Excel SharePoint and
proficient use of the worldwide web network.
Bachelors degree preferably a masters degree in science or other technically related
field or equivalent work experience.
Strong writing project management problem solving and communication skills.
Integra LifeSciences is an equal opportunity employer and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race marital status color religion sex age national origin sexual orientation physical or mental disability or protected veteran status.
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Required Experience:
IC
Employment Type
Full-Time
