Quality Manager - Belgium
Reporting to the Director QA, the QA Manager is the owner of all operational quality related activities.
The position’s main responsibilities are:
- Owner of the internal and external (supplier) audit process,
- Owner of the device testing and release processes,
- Owner of the complaint handling processes,
- Act’s as back-up PRRC,
- Provides support in promoting quality systems and company quality policies,
- Identity area’s of improvements and implement the improvements,
- Identifies risks and performs trending of complaints, deviations, and audit findings, and identifies appropriate corrective and preventative measures,
- Effectively interact with all departments of Miracor to resolve quality issues in a timely manner,
- Leads the periodic quality review meetings,
- Provides support during 3rd party audit (notified body, competent authority and customer),
- Provides support and issue resolution relating to issues that potential affecting product quality/compliance,
- Other duties as assigned by the management of Miracor.
- Excellent command (verbal and written) of English and good knowledge of French. Any other language is an asset
- Process minded
- Start-up mindset: hands-on approach, solutions oriented
- Rigorous and flexible
- Self-driven and autonomous
- Strong attention to detail and respect of regulatory obligations and quality systems
- Willing to travel occasionally
- Proximity of the domicile to Awans, Belgium is a plus
- In possession of a valid working permit and of a driving license
- Minimum 5 years experience in the quality department of a medical device regulated environment
- Eligible to act as PRRC
- Certified ISO 13485 auditor with skills in MDR
- Excellent skills in the Microsoft Office 365 applications
- Experience in validation of medical devices and/or processes is a plus
- A challenging and diversified position within a high-potential fast-growing innovative medical device company
- To work in a human size, dynamic, respectful and professional environment
- International exposure, with learning and development opportunities
- An attractive compensation package in line with the position responsibilities and your experience
Equal Opportunity Statement
We are all proud to work for such a great company as Miracor Medical. And we would be even prouder to have you on board. Whoever you are, wherever you come from, regardless of your race, religion, color, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, membership in an employee organization, retaliation, parental status, military service, or other non-merit factor. Please apply if you see a position that makes your heart beat, and if you feel the role is appealing to you. If you’re smart and good at what you do, come as you are.
Send your CV together with an adapted cover letter via Miracor Medical SA Talent Center.
Your application and related information will remain strictly confidential.