Quality Management & Process Excellence Expert

Hybrid - Upon agreement between you and your supervisor, you are entitled to a flexible arrangement where you will be able to split your time between working from the office and working remotely.

Fresenius Medical Care 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 core values supporting our promise to improve the quality of life of every patient every day. These core values are: We Care. We Connect. We Commit.

The primary role of the function is to support the creation and execution of efficient, compliant and optimized, Quality Systems processes and practices. Expectations for achieving this include interfacing and working in tandem with the Value Streams, Manufacturing, other Vertical Operational and Quality functions, and the Systems, Quality & Regulatory (SQR) organization.

The role is critical to support accessing and communicating all performance aspects that are related to the In-Center Vertical, including gathering, analyzing and presenting relevant quality data and KPIs to support evidence-based decision making.

This includes but is not limited to creating and maintaining procedures and assisting in audit preparation and execution.

The incumbent of this role takes necessary actions to ensure the efficient and timely preparation of routine reports, and data extracts to support various departments within the organization. He/ she is responsible for creating actionable evidence-based analytics to support the company's partnerships with accountable care organizations and other strategic arrangements. Other clinical analytics and project based analytical efforts including data science efforts may be assigned.

Responsibilities:

• Support and execute major quality initiatives to continuously improve the processes as well as the product quality of relevant products (especially with focus on product related processes of the QMS).

• Support implementation (optimization of fit for use and reduction of non-added value) of quality processes such as CAPA, Complaint Handling, Training, Internal/External Audit, Global Product Development Process (GPDP), Change Management, Risk Management, Management Review etc..

• Support and drive the continuous harmonization of the application of tools (like e.g. GPDM, QTRAK, QDATA) linked to the processes across the Vertical In-Center and the related units like plants.

• Support global In-Center plants to implement new or changing regulations and sustainability requirements.

• Support the establishment and maintenance of framework for Business Performance assessment that are related to e.g. product quality, customer complaints, cost of poor quality etc..

• Support coaching the functional teams to achieve compliant and efficient processes to execute their responsibilities.

• Provide key developmental and learning support to impacted stakeholders in the execution of the defined business process improvement initiatives.

• Create and maintain quality data metrics for various internal customers, reviews, reports and forums.

• Generate reports and data extracts for Quality Management, advanced analytics and research from both external and internal data sources.

• Support the assessment of potential product risks (from data reporting, prediction of performance and/or market observation and identified quality problems).

• Provide support during creation and maintenance of quality reporting for leadership.

• Investigate complex data related issues and synthesize quantitative and qualitative information using past, current, and future trending information.

• Initiate and support the analyses and investigations of quality issues.

• Establish a deep knowledge on how to perform CAPAs and review CAPAs to improve the CAPA culture. Serve also as CAPA owner for CAPAs in scope of the In-Center Product Quality & CE Supplier Quality (IC PQ & CE SQ) unit.

• Assist with various projects as assigned by a direct supervisor.

• Support external and internal audits performed within the In-Center Vertical organization as auditee (for the processes in scope of Systems, Quality & Regulatory (SQR) and the Vertical In-Center).

• Support execution of regulatory strategy by process implementation support at the sites.

• Utilization of predictive analytics and artificial intelligence (AI) to support the identification and reporting of potential and actual quality related issues.

• Deploy and maintain the global quality performance tracking and reporting process and tools supporting the In-Center global medical devices product conformity.

• Interface with design and operations quality, and other functions, globally to ensure product performance and to ensure that regulatory impacting measures are consistently gathered, reported and analyzed.

• Other duties as assigned.

Requirements:

• Degree level holder - Technical/Scientific Discipline

• More than 5 Years of related experience

• Knowledge of relevant standards and regulations – i.e. 21 CFR 820, ISO 13485, ISO 14971, etc.

• English (fluent)

• Ability to maintain professional relationships, and communication with colleagues and to internal and external customers, integrating attitude.

• High engagement in achieving the targets and in the objectives of the position, proactive and solution-oriented approach towards problems and priority setting.

• Ability to handle moderation and presentation techniques.

• Ability to handle conflict situations, building effective relationships.

• Highly developed and proven analytical and statistical skills.

• Pro-active, change & solution oriented.

• Continuous optimization approach, integrating attitude, delegation skills, drive for results.

• Process thinking and process authorship.

• Knowledge of applicable quality standards (e.g., ISO 13485, ISO 14971, EU Guidelines for GMP, 21 CFR §820, MDSAP, etc.).

• Good knowledge of medical device directives and regulations (MDD 93/42/EEC, MDR 2017/745, etc.).

• Good knowledge of internal and external processes and structures and of the Quality Management System requirements.

• Statistical Techniques.

• Required: Office (Excel/Word/PowerPoint)

• Additional: Workflow systems like Trackwise, PDM systems as PTC Windchill, Minitab

Our offer:

• 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