Senior Quality Expert (QMS)

Fresenius core values:

Fresenius Medical Care is a people business. Our success depends on having the best and brightest employees, and helping them attain their personal and professional goals while delivering excellence in patient care and business results. Our employees embody our culture which is based on six core values supporting our promise to improve the quality of life of every patient every day. These core values are: Patients and Partners First, Honesty and Integrity, Quality and Compliance, Collaboration, No-Limits Mindset and Results Oriented.

The Senior Quality Specialist plays a pivotal role in maintaining and enhancing the quality management system (QMS) within the IT department. This position is responsible for ensuring compliance with established processes, documentation, and controls to drive efficiency and quality in IT operations.

Your Responsibilities:

• Responsible for documentation management and archiving within the QMS framework.

• Conduct QMS administrative work, including maintaining records, tracking metrics, and facilitating audits.

• Design and implement DTI (Department of Information Technology) IT processes and controls, including IT Standard Operating Procedures (SOPs), Work Instructions (WIs), and systems.

• Identify training needs for DTI IT personnel to execute assigned QMS functions effectively.

• Develop training matrices and packages to support the qualification of IT personnel in implementing QMS processes.

• Develop change management strategies, including PowerPoint decks, and communication plans to facilitate smooth transitions within the IT department.

• Collaborate with cross-functional teams to ensure alignment of QMS processes with departmental goals.

• Support continuous improvement initiatives by analyzing data and identifying areas for enhancement within the QMS.

Our requirements:

• Bachelor's degree in Computer Science, Software Engineering, a Science or a related field or successfully completed a technical apprenticeship supplemented with appropriate professional experience in a comparable role 

• 1+ years of professional experience working with or owning computer software validation/system coordination 

• Strong EN ISO 13485:2016 knowledge 

• 21CFR Part 11 e-signature knowledge 

• IT service provider/department process awareness 

• GAMP 5 software validation knowledge 

• Must be knowledgeable about FDA electronic records and electronic signature requirements, and all GAMP 5 software validation requirements 

• Relevant experience with Quality system IT Platforms – e.g. Trackwise, Windchill, Agile, IQVIA etc 

• Experience of working in a company manufacturing under GxP environment

• Strong communication and project management skills as well as a strong service and result oriented working style 

• Additionally, minimum of 3 years of professional experience working in a medical device or pharmaceutical industry as well as an international environment would be preferred 

• Fluency in the English language in the business environment (at least B2)

• Knowledge of computer software validation and computer software assurance principals 

• Willingness to travel within Europe and in the US as needed to support projects. 

Our offer:

• Flexible working hours (start between 6:30 a.m. - 9 a.m.)

• Hybrid working mode (min. 2 days per week in the office)

• Private medical care in LuxMed,

• PZU life Insurance (voluntary insurance)

• Unlimited international travel Insurance (with a global range)

• Benefits System platform (120 points / month for multisport card, cinema tickets, online shopping etc.)

• Language courses reimbursement (up to 70% of course reimbursement)

• Studies reimbursement (up to 50% of study reimbursement)

• Work abroad possibility (up to 30 days / year)

• Recommendation programme (2000 PLN or 2500 PLN for successful recommendation)

• Holiday allowance (up to 800 PLN / year)

• Childcare refund (up to 900 PLN / year)

• Glasses and contact lenses reimbursement (500 PLN per year)

• Occasional gifts (e.g. 1st year anniversary gift)

• Office team building activities and events