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BD (Becton, Dickinson and Company) QA Leader - Compliance Team in Kornye, Hungary

Job Description Summary

Job Description

The main responsibilities of this position will be:

  • Define and improve the quality system:

  • Understands all quality procedures

  • Manages the documentation system and ensure that each contributor understands and knows the appropriate documents

  • Is the site representative for all BDM-PS and corporate requirements, updates and implements local procedures accordingly

  • Handles the external quality audits: customers audits, notified bodies or BD WW audits

  • Prepares and organize all external audit. Ensure each key contributor is available and prepared

  • Ensures every observation raised by the auditors is understood and is valid (no misinterpretation)

  • Owns the customer complaint process:

  • Facilitates the relation between the site and WW QA organization

  • Ensures that every internal analysis is performed on time and according to the right methodology

  • Coordinates and review the answer and the proposed action plan.

  • Owns the CAPA process:

  • Ensures that every CAPA is appropriately reported and analyzed

  • Ensures that corrective and preventive actions are staffed accordingly and completed on time

  • Manages the quality metrics:

  • Ensures the data are analyzed by the Quality management board and that objectives and actions are defined on a yearly basis

  • Owns the internal audit process:

  • Ensures that yearly audit program is defined and followed accordingly

  • Ensures corrective actions are decided and implemented

  • Owns the validation process within the plant:

  • Ensures that all validation activities are performed according to WW and local requirements

  • Ensures that validation database and local documents are maintained

  • Participates in key quality improvement projects

Required skills:

  • University/College degree – engineering or equivalent

  • Strong Quality experience, preferably in quality assurance

  • Strong leadership and managerial skills

  • Teamwork and effective communication

  • Audit experience

  • Fluent in English

  • GMP and ISO 13485 knowledge (is nice to have)

Why join us?

A career at BD means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our associates can fulfill their life’s purpose through the work that they do every day. You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program — which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components — is designed to support the varying needs of our diverse and global associates.

To learn more about BD visit https://bd.com/careers (https://jobs.bd.com/)

Primary Work Location

HUN Kornye - Uveggyar

Additional Locations

Work Shift

BD is a leading global medical technology company that creates medical technology, devices and laboratory equipment for a variety of needs across the healthcare continuum. At BD, we are looking for candidates who possess passion, innovative solutions and a commitment to our one mission of improving access to groundbreaking medical and biotechnology services for people near and far, delivering state-of-the-art technology and cutting-edge research in the battle to fight and cure infectious diseases. With a global reach that extends across 50 countries worldwide, our network of professionals collaborates on effective measures to deliver enhanced patient quality such as lower health care delivery costs, improved health care and safety, and expanded health care for all. Join our company and see how you can become a part of one global mission to make a difference in human health.

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.

All applicants should complete the on-line application process. BD is committed to working with and providing reasonable accommodations to individuals with disabilities. If you require assistance or an accommodation because of a disability to participate in the application process, please call 855-BD-HELPS (855-234-3577) or email asc.americas@bd.com

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