Quality Specialist Fixed Term Contract

BD; Wrocław; On-site; PLN 99,000 - 151,000; Full time

Job summary

BD is recruiting for a Quality Assurance professional in Wroclaw, Poland to develop and maintain QMS documentation and support regulatory inspections. The role involves root cause analysis, CAPAs, KPI reporting, and driving continuous improvement across processes with TrackWise and SAP proficiency.

You will collaborate with cross‑functional teams, deliver training on quality system requirements, and ensure compliance with MDR and ISO13485, in a fast‑paced healthcare environment.

Qualifications

• Minimum Bachelor’s Degree is desirable.
• Experience in Quality Assurance within the healthcare, medical device, pharmaceutical or regulated industry environment.
• Strong understanding of quality management systems (e.g., ISO 13485) and regulatory requirements (e.g., MDR).
• Demonstrated experience investigating quality issues, performing root cause analysis, and implementing effective CAPAs.
• Excellent analytical, critical thinking, and problem-solving skills, with the ability to interpret data and identify trends.
• Strong written and verbal communication skills in English, with the ability to effectively communicate across all levels of the organization.
• Proficient in Microsoft Office applications (Word, Excel, PowerPoint) and electronic QMS platforms (e.g. Trackwise, SAP).
• Ability to work independently and as part of a team in a fast‑paced environment.

Responsibilities

• Develop, maintain, and continuously improve Quality Management System (QMS) documentation, including procedures, work instructions, templates, and forms, ensuring alignment with applicable regulatory and business requirements.
• Support regulatory inspections, certification audits, and internal and external audits by preparing documentation, coordinating responses, and providing subject matter expertise as required.
• Investigate quality-related issues, nonconformances, and customer complaints, conduct root cause analysis, and support the implementation and effectiveness verification of corrective and preventive actions (CAPAs).
• Monitor, analyze, and report quality system metrics and key performance indicators (KPIs), identifying trends and opportunities for improvement.
• Deliver training and support employee awareness of quality system requirements, while driving continuous improvement through process evaluations, gap assessments, and enhancement initiatives.
• Coordinate quality system databases, trackers, and electronic systems (e.g., TrackWise, SAP, C2C), ensuring data accuracy and timely completion of assigned activities and actions.
• Lead and support Quality Systems projects and improvement initiatives, acting as a Subject Matter Expert (SME) for assigned processes and responsibilities as defined within QMS documentation.
• Collaborate with cross-functional stakeholders to support quality system compliance, issue resolution, and implementation of process improvements.

Education

Bachelor's Degree

Job description

We are the people who give possibilities purpose. 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.

Job Description

Job Responsibilities

• Develop, maintain, and continuously improve Quality Management System (QMS) documentation, including procedures, work instructions, templates, and forms, ensuring alignment with applicable regulatory and business requirements.
• Support regulatory inspections, certification audits, and internal and external audits by preparing documentation, coordinating responses, and providing subject matter expertise as required.
• Investigate quality-related issues, nonconformances, and customer complaints, conduct root cause analysis, and support the implementation and effectiveness verification of corrective and preventive actions (CAPAs).
• Monitor, analyze, and report quality system metrics and key performance indicators (KPIs), identifying trends and opportunities for improvement.
• Deliver training and support employee awareness of quality system requirements, while driving continuous improvement through process evaluations, gap assessments, and enhancement initiatives.
• Coordinate quality system databases, trackers, and electronic systems (e.g., TrackWise, SAP, C2C), ensuring data accuracy and timely completion of assigned activities and actions.
• Lead and support Quality Systems projects and improvement initiatives, acting as a Subject Matter Expert (SME) for assigned processes and responsibilities as defined within QMS documentation.
• Collaborate with cross-functional stakeholders to support quality system compliance, issue resolution, and implementation of process improvements.

Education And Experience

• Minimum Bachelor’s Degree is desirable.
• Experience in Quality Assurance within the healthcare, medical device, pharmaceutical or regulated industry environment.
• Strong understanding of quality management systems (e.g., ISO 13485) and regulatory requirements (e.g., MDR).
• Demonstrated experience investigating quality issues, performing root cause analysis, and implementing effective CAPAs.
• Excellent analytical, critical thinking, and problem-solving skills, with the ability to interpret data and identify trends.
• Strong written and verbal communication skills in English, with the ability to effectively communicate across all levels of the organization.
• Proficient in Microsoft Office applications (Word, Excel, PowerPoint) and electronic QMS platforms (e.g. Trackwise, SAP).
• Ability to work independently and as part of a team in a fast‑paced environment.

Fixed Term Contract

Why Join Us?

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 healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.

We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face‑to‑face collaboration supports your learning, your progress, and your success.

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.

Required Skills

Optional Skills

Primary Work Location

POL Wroclaw - Legnicka

Additional Locations

Work Shift

At BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance‑based culture, as well as a competitive package of compensation and benefits programs. You can learn more on our career site under "Our Commitment to You."

Our salary or hourly rate ranges reward associates fairly and competitively. We regularly review these ranges and factors, such as location, contribute to the range displayed.

Our pay is based on the role and the necessary skills and education to perform it successfully. The salary or hourly rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location. Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role.

Salary Range Information

zł99,000.00 - zł150,975.00 PLN Annual