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Senior Quality Manager, Sterilization Assurance

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Company :
CareFusion

Location :
Covington, Georgia

Expiry Date :
Mon, 08 Mar 2021 23:59:59 GMT

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Description :
Job Description Summary Job Description SUMMARY The Sr. Quality Assurance Manager in Sterilization is responsible for the compliance of the Quality Systems within BD Interventional Sterilization (BDIS) inCovington and Madison, Georgiato meet the Corporate and industry standards for quality system requirements in sterilization processing for BD. The Manager is the main contact for quality related issues, product release requirements, corrective action/preventive action programs, process improvement projects and compliance programs within Regional Sterilization. ESSENTIAL DUTIES AND RESPONSIBILITIES – Manages all aspects of the quality system within BDIS to include supervision of the lot release QA personnel, Quality Engineer and QA Supervisor. – Ensures compliance to divisional, Corporate, AAMI, ISO and EN requirements and maintains all sterilization QA related procedures. – Assist in development of strategic initiatives related to BD Sterilization Operations. – Participate in Regulatory agency (EPA, OSHA, FDA, and ISO) visits/audits. – Manages the product on-loads into BDIS with all divisional project teams and coordinates testing forsterilization adoptions. – Assists Validation Technical team with cycle development and validation scheduling. – Oversees updates of specification sheets and performs approval. – Manages improvement projects, sterilization CAPA program, and disposition of non-conformances. – Oversees the EO Personnel monitoring program. – Leads and Supports in Regulatory agency (EPA, OSHA, FDA, AND ISO) visits/audits at all locations supported by BD Global Sterilization. – Performs supplier and contract sterilization audits as needed. – Other duties as assigned. QUALIFICATIONS: – Must possess the ability to work independently and provide leadership to others – Must be detail oriented – Must possess knowledge about the physical, chemical, and biological sciences – Must understand impact of environmental control packaging, and manufacturing process on sterility assurance – Thorough understanding of EO and Gamma/E-Beam sterilization validation methods – Knowledge of all sterilization methods for medical devices – Must be current on government regulations and international regulations regarding the sterilization of medical devices – Knowledge of hazardous chemical handling – PC literate, able to work with basic computer software programs (Microsoft Word, Access, Teams, and Excel). Knowledge of Statistical software – Strong interpersonal skills required in the areas of verbal and written communications, customer focus, professionalism, telephone courtesy, influencing, and team building. EDUCATION and/or EXPERIENCE : – Minimum of a Bachelors degree in Engineering or Science. – Minimum of seven (7) years experience in medical device industry – Minimum of five (5) years of experience with EO sterilization of medical devices, preferred – Minimum of five (5) years of supervisory or management experience Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. #LI-PRO Primary Work LocationUSA GA – Covington BMD Additional LocationsUSA GA – Madison Work Shift