About our Client
Man and Science is at the forefront of developing groundbreaking neuromodulation devices for the treatment of severe headaches. Our client's mission is to improve patients' quality of life through high-quality, innovative technologies. They are seeking a dedicated Quality Engineer with a strong focus on subcontractor management to ensure that their external partners meet their stringent quality standards and support the successful development of their products.
As
a Quality Engineer specializing in subcontractor management, you will be
responsible for overseeing the quality and performance of our client's external
suppliers and manufacturing partners. This includes managing supplier audits,
ensuring compliance with regulatory standards, and working closely with
subcontractors to ensure that all components and services meet our
specifications. You will play a key role in ensuring that their products are
delivered on time and to the highest standards of quality, without overlaps
with the V&V and regulatory teams.
Your role
- Subcontractor Quality Management: Develop and maintain quality agreements with subcontractors, ensuring that all partners adhere to Man and Science’s quality and regulatory requirements (ISO 13485, FDA 21 CFR Part 820).
- Supplier Audits: Plan and conduct regular audits of subcontractors to verify compliance with applicable standards and contractual requirements. Ensure that audit findings are addressed promptly.
- Non-Conformance Resolution: Work closely with subcontractors to investigate and resolve any non-conformances. Implement corrective and preventive actions (CAPA) to ensure that similar issues do not arise in the future.
- Supplier Performance Monitoring: Develop metrics and reporting systems to monitor supplier performance, including delivery timelines, product quality, and adherence to specifications. Provide regular updates to senior management.
- Process Improvement with Subcontractors: Identify opportunities for process optimization and quality improvements at subcontractor sites. Work collaboratively with external partners to implement best practices.
- Documentation & Compliance: Ensure that subcontractor-related quality documentation, such as inspection reports, audit findings, and CAPA actions, are properly maintained and meet regulatory standards.
- Collaboration with Internal Teams: Coordinate closely with internal teams, including V&V and regulatory, to ensure that all subcontracted activities align with overall project timelines and requirements.
- Training & Support: Provide training and support to subcontractors on quality expectations, regulatory requirements, and process improvements.
Your profile
- Education: Bachelor’s or Master’s degree in Quality Engineering, Biomedical Engineering, or a related field.
- Experience: 3+ years of experience in quality engineering, with a strong focus on managing subcontractors or external manufacturing partners in the medical device industry.
- Supplier Quality Management: Proven experience in managing supplier quality, including conducting audits, resolving non-conformances, and overseeing corrective actions.
- Regulatory Knowledge: Strong knowledge of ISO 13485, FDA 21 CFR Part 820, and other relevant medical device regulations.
- Process Improvement: Experience with Lean, Six Sigma, or other process improvement methodologies, particularly in external manufacturing environments.
- Problem-Solving: Excellent analytical skills with a proven ability to perform root cause analysis and implement CAPA solutions.
- Communication Skills: Strong interpersonal and communication skills, with the ability to build relationships with external partners and convey quality requirements effectively.
- Project Management: Experience in managing multiple subcontractor relationships simultaneously while keeping projects on track
Our client's offer
- Impact: Your work will directly ensure the success of our client's subcontractor partnerships, critical to delivering high-quality products.
- Growth Opportunities: As a growing company, there is ample opportunity for professional development and advancement.
- Collaborative Environment: Join a dynamic and multidisciplinary team focused on improving patient outcomes through innovation.
Person in charge
Morgane de Jong - Recruitment Consultant
Office : +32 10 39 21 84
Mail : mdejong@plusonesearch.be
