Job Description Summary=== BE PART OF SOMETHING BIGGER! ===
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.
Based in Winnersh and reporting to the Principal Quality Systems Engineer, MMS International Infusion, you will provide support and expertise in the daily running of Quality Management System (QMS), Service and Repair process, Engineering Change Orders and Post Market Surveillance activities. Through proactive communication across organization, effective problem solving and active vigilance on applicable requirements, you will drive compliance and effectiveness for assigned QMS processes. You will also be expected to develop and participate in the deployment of approved Quality Plans across the organization to support defined strategies and objectives.
Main responsibilities will include:
- QMS support and MMS Engineering change control processes for the BD Winnersh facility, and MMS Infusions UK Service and Repair facility in Worthing. Includes: managing change control and updating QMS documents
- Lead Repair-Related Complaint process driving investigations and providing feedback.
- Conduct analyses of serviced products to identify root causes of failures.
- Preparation of QMS Metric reporting and Post Market Surveillance (PMS) activities. Includes: PMS/PSUR Plans and Reports and Service support activities.
- Participate in Product Transfer teams to assist in developing service repair processes for new or transferred products.
- Plan, develop and conduct Service Manual and Service work instruction validations (IQ, OQ, PQ), test method validations, inspection method validations.
- Quality support for regulatory and business tools supporting EUDAMED.
- Lead and support ongoing Quality Improvement projects and initiatives.
- Supporting the development and maintenance of supplier qualification activities for the Service organization (Global Customer Services).
- Perform other duties as assigned.
To be successful in the position you will have a technical degree with a minimum of 2 years of relevant experience, or work experience of a minimum of 5 years ideally within the medical device industry, however candidates from other highly regulated environments will also be considered. You will have strong knowledge of worldwide applicable regulations for Quality Systems (EU MDR, ISO13485, 21CFR820 etc), and the ability to collect data, analyse situations and propose optimal process solutions to meet both Compliance and Business requirements. A strong ability to prepare written technical plans and reports in support of PMS/PSUR, engineering changes, product or process validations, and failure investigations is important as is a working knowledge on managing life cycle documents and records and understanding of change control and training process requirements.
Additional Qualifications / Experience
- Knowledge of electro-mechanical medical devices (preferred).
- Experience in a customer focused Service organization (preferred).
- Experience in supplier/internal auditing would be an advantage.
- Computer literacy in Microsoft Outlook, Word, Excel, a working knowledge of Microsoft Access or TrackWise complaints handling software would be an advantage.
- Ability to travel as required to support business activities.
Click on apply if this sounds like you!
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.
Becton, Dickinson and Company is an Equal Opportunity 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, or any other protected status.
To learn more about BD visit https://emea.jobs.bd.com/
Primary Work LocationGBR Winnersh - Eskdale Road
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