Job Description Summary
The Senior Quality Systems Specialist is accountable for support of the continued development,
improvement, and implementation of the Quality Systems. This position actively participates in quality
guidance and supports project and quality teams in continuous improvement activities.
Acts as a Subject Matter Expert in one or more Quality systems. Supports the plant in identification and resolution of quality and/or compliance issues assuring compliance with IVDR, FDA regulations, ISO standards, corporate directives, and company strategies.
Job Description
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.
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Why join us?
A career at BD means learning and working alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time.
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.
Become a maker of possible with us!
Quality systems:
- Collects, interprets, and analyzes data and presents to others either orally or in writing.
- Understands published Quality System and Regulatory agency requirements and leverages best practices. Makes recommendations for project direction including alternative solutions.
- Independently designs quality plans consistent with project objectives. Readily applies Quality System principles to the solution of moderate/high scope and complexity challenges.
- Acts independently and consults with management on more complexed topics.
- Develops, documents, administers, and maintains Quality Systems for conformance to regulatory requirements and company policies.
- Represents BD Drachten on cross-site/business unit teams related to Quality Systems.
- Partners with other quality professionals to address recurring issues identified throughout the organization.
- Provides and analyzes site quality metrics as required to assess the effectiveness of quality system improvements.
General responsibilities include:
- Maintains and improves site Quality System documentation including, but not limited to, development of policies and procedures as appropriate to comply with ISO 13485, GMP 21 CFR Part 820 and EU IVDR.
- Ensures quality system improvement and standardization initiatives within the business are implemented on site
- Working knowledge of Quality System Regulatory requirements and application to Company/Unit/Site requirements.
- Initiation and/or support of CAPAs. May lead the investigation/corrective action process
- Uses tools for risk analysis/management, 8D, validation, and project management, sampling plans, Six Sigma, control plans, design control and trending.
- Supporting and/or owning Situation analyses investigations.
- Assists with external and corporate audit readiness
- Preferably acts as an internal auditor and is a main auditee for processes it supports.
Position-Specific responsibilities include the following:
- Managing site CAPA program and acts as an SME for CAPA and root cause analyses.
- Manages Site Audit program including internal and external audit governance.
- Acts as a Quality systems representative in Change control processes.
- Metric Development and maintenance - manages, improves, and maintains Quality Systems data integrity (includes but not limited to: CAPA, complaints, audits, non-conformities and other quality systems). Responds to internal and external requests for data through the preparation of ad-hoc queries and reports.
- Act as technical expert support for the EU IVDR requirements and supports site implementation and maintenance of EU IVDR requirements.
Education and Experience:
Bachelor's degree in engineering/life science and technology areas with minimum 5 years of relevant experience or master's degree with minimum of 3 years of relevant experience
Knowledge and Skills:
Knowledge:
- Knowledge of EU and International regulations and standards that apply to the medical device industry including FDA Quality Systems Regulations, ISO 13485, IVDD, EU IVDR, MDD, EU MDR etc.
- Ability to speak with clarity and manage conflict resolution in a variety of settings: one-on-one interactions, group meetings, and formal presentations.
- Knowledge and understanding of Risk Management and Corrective/Preventative Actions processes.
Skills:
- Trackwise, technical writing, auditing experience preferred.
- Excellent communication skills at all levels, both written and verbal.
- Ability to perform multiple tasks and prioritize workload.
- Effective analytical, technical, and problem-solving skills.
- Effective meeting and presentations skills.
- Self-motivated /directed
Click on apply if this sounds like you!
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.
Required Skills
Optional Skills
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Primary Work Location
NLD Drachten - Marconilaan
Additional Locations
Work Shift