Job Description Summary
The Quality Assurance Specialist role plays an important part in the maintenance of the Quality Management System according to ISO 13485, EMEA and global procedures. BD is seeking a detail-oriented individual supporting regional quality processes and computer system validation activities.As a member of the EMEA Regional Quality Assurance Team, the Quality Assurance Specialist is responsible for contributing towards and supporting the quality objectives and initiatives including the standardization and simplification of a Quality Management System.
Job Description
Main responsibilities will include:
- Maintaining Quality Management System according to ISO 13485, EMEA and global procedures.
- Ensuring that all GxP‑relevant computer systems are validated with a risk-based approach, maintained in a compliant state, and operate consistently according to regulatory requirements and internal quality standards. This role supports system implementations, upgrades, process improvements, audits, and lifecycle management activities to ensure data integrity, product quality, and patient safety.
- Create and execute CSV validation deliverables (URS, IQ/OQ/PQ protocols, reports) and manage deviations/CAPAs.
- Be responsible for the continual improvement of Quality System documents including writing procedures, work instructions and forms/templates in collaboration with departments and ensure adherence to them.
- Promoting the awareness of applicable Quality Management System Requirements.
- Collaborating with key stakeholders and internal functions to ensure required quality requirements are established, maintained and improved.
- Oversee change control, evaluate impacts of system updates, and maintain validated state through ongoing monitoring.
- Maintain audit‑ready documentation and collaborate with QA on reviews and approvals.
- Deliver training and drive continuous improvement in validation processes, templates, and risk‑based approaches.
To be a successful candidate you will have:
- Proficient command of English language required (written and spoken).
- University degree level required (minimum bachelor’s degree).
- Understanding of computer system validation process and deliverables.
- Positive Quality attitude and excellent communication skills.
- Ability to work independently and manage time effectively.
- Willingness to work in detail-oriented way and to seek improvements.
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.
Why join us?
BD is proud to be certified as a Top Employer 2025 in Poland, reflecting our commitment to creating an exceptional working environment.
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!
Click on apply if this sounds like you!
At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.
Becton, Dickinson and Company is an Equal Opportunity Employer. We evaluate applicants without regard to 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, and other legally-protected characteristics.
To learn more about BD visit: https://bd.com/careers
Required Skills
Collaborating, Computer System Validation (CSV), Continuous Improvement, Problem Solving, Quality Management Systems (QMS), Quality Standards, Validation ProcessesOptional Skills
.
Primary Work Location
POL Wroclaw - LegnickaAdditional Locations
Work Shift
At BD, we are strongly committed to investing in our associates—their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You.
Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates’ progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed.
The salary or hourly rate offered to a successful candidate is determined by their experience, education, and skills, as well as the labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location.
Salary Range Information
zł91,500.00 - zł139,575.00 PLN AnnualRecommend
to a friend
Approve
of CEO
"Purpose driven company where associates work every day to make healthcare better. A lot of great initiatives going on to make BD the best MedTech company in the world."
Anonymous, Franklin Lakes, NJ