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The Senior Quality Engineer II - Health Hazard Evaluation (HHE) - works cross functionally to complete 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.

+ 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:

+ Bachelor's degree with 8+ years of experience or equivalent education and years of experience

+ Master's degree with 5+ years of experience or equivalent education and years of experience

+ Doctoral degree with 3+ years of experience or equivalent education and years of experience

+ Senior level professional with advanced knowledge and experience

+ Works on complex projects or processes with limited oversight

+ Requires a full understanding in an area of specialization or a range of knowledge and skills in own job discipline

+ Applies analytical, technical and problem-solving skills and experience to resolve complex problems or non-standard situations

+ Has awareness of external commercial and regulatory factors that may impact own job discipline

+ Works independently within broad guidelines, policies and the operational plan to impact a range of customer, operational, project or service activities within own team and other related teams

+ Manages complex processes

+ Gains cooperation of others within and outside of own department

+ Interprets and explains information to internal and external audiences who are not familiar with the subject matter often requiring persuasion

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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