Quality Systems Specialist
Quality System Specialist
As a Quality System Specialist, you will be responsible for ensuring that the quality system is functioning adequately for Pont de Claix Campus but also supporting the quality system across worldwide sites (Mexico, UK, US, etc). 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-conformances 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
To deliver the results that we are looking for, you are graduated in Engineering or similar scientific discipline and you have minimum of 3 years of experience in a regulated industry.
You have at least a basic knowledge of regulations, preferably those of medical devices (such as ISO13485, 93/42/EEC, 21CFR820) or pharmaceutical products (Eur GMP, 21CFR210/211).
You have some 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.).
Additionally, you are well organized and open-minded person with exceptional communication skills.
You are able to work autonomously in a busy, multicultural environment.
Finally, you speak English fluently.
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)
To apply for this job please visit jobs.bd.com.