Faites partie de quelque chose de plus grand chez BD. Ici, vous nous aiderez à améliorer continuellement la façon dont nous faisons les choses chaque jour ; pour être plus efficace, plus performant et mieux servir nos clients. Vous ferez cela au sein d'une équipe exceptionnelle qui s'efforce de s'assurer que tout ce que nous faisons est conforme aux réglementations et aux normes, non seulement parce que c'est la bonne chose à faire, mais aussi parce que nos produits ont un impact sur la qualité de vie des gens. Ici, vous mettrez votre expérience en matière de conformité, vos attentes élevées et votre souci du détail au service du meilleur : faire progresser le monde de la santé™. Chez BD, vous pouvez faire une véritable différence d'une personne.
Job Description SummaryThe Quality Assurance Manager for the Covington BD Interventional Sterilization (BDIS) site is responsible for the compliance of the Quality Systems at the site to meet the BD Corporate, Business Unit, and industry standards for quality system requirements for terminal sterilization processing for BD products. The QA Manager is the main contact for quality related issues, product release requirements, corrective action/preventive action programs, process improvement projects, and compliance programs within BD Interventional Sterilization. This job requires the manager to be onsite 5 days a week to support the operation of the sterilization site.
We are the makers of possible
BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.
We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
Manages all aspects of the quality system within Covington BD Interventional Sterilization to include supervision of the lot release QA personnel, Quality Engineer(s), and QA Specialists (as applicable).
Ensures compliance to Business Unit, Corporate, AAMI, ISO and EN requirements and maintains all sterilization QA related procedures and processes.
Assist in development of strategic initiatives related to BD Sterilization Operations at the Covington site.
Participates and leads Regulatory agency (EPA, OSHA, FDA, and ISO) visits/audits.
Works with the Validation/Technical team and/or Global Sterilization (GSA) team for product on-loads into the Covington sterilization site.
Coordinates completion of BD Interventional Sterilization adoptions as needed with the project teams, GSA, and the Validation/Technical team.
Assists Validation/Technical team with cycle development and validation scheduling, as required.
Oversees updates of sterilization specification sheets and works with the QA heads for the various manufacturing sites/Business Units to obtain approvals.
Manages improvement projects, sterilization CAPA program, and timely disposition of nonconformances.
Oversees the EO Personnel monitoring program for the site.
Performs supplier audits as needed.
Other duties as assigned by Director of Quality Assurance.
QUALIFICATIONS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
Must possess the ability to work independently and provide leadership to others, including both exempt and non-exempt staff.
Must be detail oriented and able to manage time appropriately.
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 Ethylene Oxide sterilization validation methods.
Must have a strong understanding of medical device quality management systems and medicinal product quality management systems.
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, 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 an engineering or biological science.
Minimum of five (5) years experience in medical device industry.
Three (3) years of experience with Ethylene Oxide sterilization of medical devices preferred.
Minimum of five (5) years of supervisory or management experience.
LANGUAGE SKILLS: Excellent written and verbal communication skills. Ability to prepare technical reports and write technical procedures. Ability to articulate ideas clearly, lead effectively, and communicate with multiple levels of the organization.
MATHEMATICAL SKILLS: Ability to apply mathematical concepts such as algebra, calculus and statistics.
REASONING ABILITY: Position requires strong decision making skills. Ability to effectively manage day to day decisions concerning sterilization quality issues and projects. Ability to interpret and implement internal, domestic, and international guidelines within the limits of the organization. Good judgment is crucial. Determining what is absolutely necessary and ensuring compliance with limited parameters is imperative. Decisions are made frequently regarding processes, product release, projects, and corrective actions.
A high level of initiative is required. Day-to-day decisions about processing results and personnel management are made frequently. Position may interface with internal and other Business Unit employees of all levels, contractors, and regulatory agencies.
PHYSICAL DEMANDS: While performing this job, the employee is regularly required to sit, use hands to fingers, handle or feel, reach with hands and arms, and talk/hear. The employee frequently is required to stand and walk. The employee is required to climb or balance and stoop, kneel, crouch or crawl. Must have the ability to lift occasionally at least 25 pounds. Specific vision abilities required by this job include close vision and distance vision. lift and /or move up to 25 pounds. This job includes detailed close vision work.
WORK ENVIRONMENT: This position works in a normal office environment, as well as a warehouse environment. The noise level in the work environment is quiet to moderate. Occasionally, the employee will be in hot and humid conditions, near moving mechanical parts, or have the potential to be exposed to toxic or caustic chemicals. This job requires the manager to be onsite 5 days a week to support the operation of the sterilization site.
For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.
Why Join Us?
A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.
To learn more about BD visit https://bd.com/careers
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.
Primary Work LocationUSA GA - Covington BMD
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