Quality Specialist

Quality Specialist

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. To learn more about BD visit https://bd.com/careers. 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.

Primary Work Location POL Wroclaw - Legnicka

Salary Range Information zł99,000.00 - zł150,975.00 PLN Annual