Description
We are currently partnered with the fastest-growing global diagnostic companies and a market leader in the areas of Molecular Diagnostics and Clinical Diagnostics. The company offers a range of high-end instruments into both clinical and industry settings with a focus on areas such as Immunoassay Systems & Immunoanalysers, Automated Molecular Analysis, Molecular Diagnostics Instruments (PCR), Autoimmunity and supporting consumables & reagents.
This global company has a smaller, close-knit team overseeing the BeNeLux region and it is this group who are now looking to bring in a Quality Assurance & Regulatory Affairs Manager to implement and maintain the quality management systems for both new product introduction and the current product portfolio.
Key Responsibilities:
- Maintain and simplify the quality management system following the requirements outlined in ISO9001 & ISO13485 standards
- Train and assist all employees on the quality management system, company processes, and QMS procedures and to promote the awareness of customer requirements throughout the organisation.
- Ensure the correct handling and validation of all customer complaints, credit notes, and back shipments
- Report to management on the performance of the quality management system, and advise management on quality-related improvements/changes.
- Reports of KPIs, analysis of complaint statistics, credit note statistics, and returned product statistics with a view of simplifying the QMS
- Perform internal department audits and follow up on corrective and preventive actions. Initiate actions in the event of non-conformity related to products and services, providing solutions on quality improvement whilst ensuring all quality records are up to date.
- Update and maintain the risk management file: establishing risk acceptability criteria, risk analysis, risk evaluation, risk control, and monitoring.
- To destroy stock (Expired, damaged, quarantine, instruments, biohazard waste) in cooperation with the F&A department according to local legislation.
- Supervising delivery or installation of non-conforming products whilst supervising the quarantine area
- Follow up on regulatory requirements BE, NL, and LU and assure availability of valid standards or directives applicable for Menarini Benelux N.V.
- Keep legal and technical files up to date per product line.
Requirements:
- Bachelor’s degree in Business Administration, Business Operations, Quality Assurance, Six Sigma Certification or similar
- At least 3 years of experience in Quality Assurance or Regulatory Affairs roles within the life sciences
- A deep understanding of ISO standards including ISO13485 & ISO9001
- The ability and understanding to implement local regulatory requirements related to medical devices and/or IVD medical devices.
- Able to communicate and motivate via written media
- Must be adept in the use of MS Office, particularly Excel, Word, Adobe Acrobat, Visio, internet and email, and in-house specific computer software.
- Driven by a commitment to high-quality standards within a commercial environment,
- Fluent in oral and written Dutch and English
- An understanding of oral and written French would be preferable but not essential
What's in it for you:
- A competitive base salary
- Growth opportunities with a pathway to Quality Lead role
- Company Car
- Health insurance
- Phone & Internet subsidy
If you are interested in a call to discuss this further please apply or forward your resume directly to elliot.green@mackinnon-bruce.com
