BD (Becton, Dickinson and Company) Senior Quality Systems & Auditor Specialist in Columbus (East), Nebraska
Job Description Summary
BD Medical - Pharmaceutical Systems is a global leader in supplying the pharmaceutical industry with innovative, high-quality, clinically-proven and customized pre-fillableparenteral drug delivery systems. Our offering includes an extensive portfolio of pre-fillable syringes, self-injection systems, safety and shielding solutions. Our products are designed to protect, package and deliver drug therapies and to maximize healthcare worker and patient safety.
You will join our Worldwide Systems Quality department.
You are r esponsible for ensuring the quality system is functioning adequately for Pont de Claix Campus and supporting the quality system across all PS sites (Mexico, UK, US etc).
You are the one who can make the difference. Join us and be a crucial part of advancing the world of health!
Quality System Specialist
You will be cooperating closely with your Manager in supporting the internal and external audits and ensuring the quality system is updated to continually meet regulatory requirements as well as internal needs.
You will act as point of contact for supporting questions from Customers and external Auditors related to quality systems and regulations.
Lead auditor for internal audits;
Help drive solutions
Supporting closure of audit non-conformance across all Pharm Systems sites;
Coordinates and/or hosts external audits (customer, government, etc.);
Trend internal and external audit findings;
Updating quality systems procedures for on-going compliance and supporting efficient & streamline processes;
Incorporating risk-management into the quality system;
Stay up-to-date on industry best practices and regulations to support an effective quality system;
Support global quality initiatives to enhance and harmonize the quality system across the business
You are graduated in Engineering or similar scientific discipline,
Minimum of 3 years in a regulated industry.
You have experience in internal audits.
You have knowledge of regulations, preferably those of medical devices (such as ISO13485, 93/42/EEC, 21CFR820) or pharmaceutical products (Eur GMP, 21CFR210/211).
You have knowledge of technical writing and writing for complaints and you know some technical principles & tools (such e.g. statistical process methods and application, measurement systems analysis, basic quality tools: pareto, box plots, histograms, etc.).
Finally, you speak English fluently.
Additionally, you are well organized and open-minded person with exceptional communication skills.
You are able to work autonomously in a busy, multicultural environment.
If this describes you and your career aspirations, then please click on the APPLY button.
Interested in a career with BD, but this position doesn’t fit your skills and experience? Join our external EMEA Talent Community here: http://bd.tal3nt.community/
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 Location
FRA Le Pont-de-Claix Cedex
ESP Zaragoza, GBR Swindon - Dorcan, Hungary, MEX Cuautitlan Izcalli - Distribution Ctr, SGP Tuas - Tuas Plant, USA NE - Columbus (East)