Quality System Specialist
Job Description SummaryQuality System Specialist
Are you Quality driven? Are you passionate about the Medical Industry? Then, this is the job you are looking for! At BD Kiestra, we are looking for someone to join our Quality Team.
This position based in Drachten is created to support regional efforts within BD´s Integrated Diagnostics Solution segment quality organization in the EMEA Region. You will be responsible for implementing IVDR requirements, leading Post Market surveillance activities, support Regional supplier quality management, foster a metric driven site quality performance, and provide support to local site with quality challenges (e.g., filing of IVDs, facilitating global quality initiative implementation, complaint handling, etc.).
1. Implement IVDR requirements
- Linking to the global IVDR implementation team and local sites
- Completion of gap analysis to new requirements
- Creation and execution of quality plan to meet new IVDR requirements
- Support site closure of gaps identified regarding IVDR
- Support notified body audit preparation and handling related to IVDR
2. Post Market Survaillance (PMS) activities
- Creation and execution of Post Market Surveillance in accordance with regulatory and internal requirements and lead the cross functional PMS team. This includes, but is not limited to:
- Creation, approval, storage, and maintenance of PMS plans.
- Assisting Complaint handling staff in generating Post Market Surveillance data (reactive post-market surveillance) and translating into PMS report
- Compiling, finalizing, storing, and maintaining PMS reports
- Follow up on PMS outcomes (e.g., initiating corrective and preventive actions, Update of Risk management files, etc.).
3. Regional supplier quality/distributor management
- Link to global supplier management program and represent the EMEA Region
- Develop and implement a Regional supplier quality management strategy
- Ensure that BD distributors adhere to the requirements of IVDR
- Drive and monitor strategy implementation with representatives from local sites in the EMEA Region
- Follow up on supplier issues, facilitate root cause identification to these issues, ensure results are translated into improvement actions
4. Metric driven quality performance management
- Support the Regional quality performance management process by implementing and monitoring relevant metrics at Site and Regional level
- Regularly document the performance
- Together with the sites define improvement activities and follow up on them
5. Support to local site
- Support local sites hands on with IVDR implementation (e.g., tech file completion, process implementations for IVDR) and other quality challenges on a case-by-case basis
- Support local Complaints handling staff in extracting, generating and visualizing data required for various purposes (e.g., PMS, Local and Unit Management reviews, etc.), complaint analysis though root cause analysis process and documenting outcomes, creating, and reporting overview of reportable events including Medical Device Reports (MDR), Vigilance Reports and Field actions as necessary.
- Support roll-out of Global and Regional quality initiatives (e.g., Inspire quality), improvement projects (e.g., logistics and transport quality improvements) and quality system implementations (e.g., One audit, new change control system) and drive site implementation
As our future colleague
You typically require a bachelor’s degree in science, engineering, or other relevant field with a minimum of 3 years with quality experience or a combination of equivalent education and proven experience. Knowledge of the FDA medical device quality system regulations and international quality system standards/regulations (e.g., 21 CFR Part 820, ISO 13485, EU MDR/IVDR).
Further requirements are:
- Good knowledge of IVDR/MDR.
- Understanding of Quality Systems regulations.
- Experience with Post Market Surveillance activities.
- Good understanding of root cause analysis process, statistical tools, and validations.
- Very good knowledge of the common software applications (Access, Excel, Word, Power Point).
- Ability to prepare and transform data into information that can be used for presentation and documentation purposes.
- Proficiency in English is a must!
A professional challenge in a highly motivated team, a global environment and with long-term perspectives. A familiar working atmosphere in an innovative environment where your opinion matters. Diversity characterizes our corporate culture, and we are convinced that it makes us a stronger team. We value each person as an individual with their abilities and needs. In this sense, we welcome applicants who wish to work part-time, people with severe disabilities and applicants of any gender.
Do you see yourself in this position? We are already looking forward to welcoming you to the team!
Primary Work LocationNLD Drachten - Marconilaan
Work ShiftNL 40 Hr M8T8W8T8F8 (Netherlands)
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