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 what's 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 HHE's and maintain the corporate working and completed HHE archive files + Participate in, and where appropriate lead, team meetings and activities where + investigation findings and HHE's are discussed and developed to the point of approval. + Assure HHE documentation is complete, accurate and addresses regulatory + requirements prior to approval. + Provide approved HHE's 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 HHE's. + 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 integra's + 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 HHE's, 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. + Bachelor's degree, preferably a master's 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. This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices: EEO Is the Law (https://www.eeoc.gov) | EOE including Disability/Protected Veterans (https://www.eeoc.gov/eeoc/publications/ada\_veterans\_employers.cfm) Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA (https://www.eeoc.gov/eeoc/publications/fs-ada.cfm) . If you have difficulty using our online system due to a disability and need an accommodation, please email us at careers@integralife.com. Integra - Employer Branding from Integra LifeSciences on Vimeo (https://player.vimeo.com/video/265760526)