Main accountability: The Quality Manager will lead and manage the Quality Assurance (QA) and Quality Control (QC) processes at our medical device production site : · ensure compliance with all relevant regulations, standards, and Barco policies.
The role involves overseeing the quality management system (QMS), driving continuous improvement initiatives, and ensuring that all products meet or exceed customer and regulatory requirements.
· responsible for integrating quality into the design and development process, ensuring that new products are designed with quality and compliance at the forefront The Quality Manager will be a key player in maintaining the highest levels ofproduct safety, efficacy, and reliability.
Quality Management System (QMS): - Implement, and maintain the Barco Quality Management System within the site; - Lead internal and external audits in the site, including FDA, ISO, and customer audits.
Ensure timely and effective resolution of audit findings and implementation of corrective actions; - Manage local documentation control, ensuring all procedures, work instructions, and records are current, accurate, and compliant.
Quality Assurance & Control: - Oversee incoming, in-process, and final product inspections to ensure conformity with specifications and standards; - Develop and maintain quality control plans, sampling plans, and testing protocols; - Manage non-conformance reporting and lead root cause analysis, corrective, and preventive actions (CAPA).
Quality in Design & Development: - Collaborate with the R&D and Engineering teams during the design and development phases to ensure that quality considerations are embedded from the outset.
- Participate in design reviews, risk assessments, and validation activities to ensure that products are designed for manufacturability, safety, and compliance.
- Ensure that design controls are properly implemented and documented, in line with regulatory requirements.
- Monitor the transfer of designs to production, ensuring that quality standards are maintained throughout the transition.
Regulatory Compliance: - Ensure that all products are manufactured in compliance with applicable regulations, including FDA, EU MDR, and other relevant global standards.
- Liaise with regulatory bodies and maintain up-to-date knowledge of changes in regulations and standards.
Continuous Improvement: - Identify and implement process improvements to enhance product quality, reduce waste, and increase efficiency.
- Foster a culture of quality and continuous improvement across the production site.
Team Leadership & Development: - Lead, mentor, and develop the quality team, ensuring high levels of competence, motivation, and performance.
- Conduct regular performance reviews and provide ongoing training and development opportunities for the team.
Customer Focus: - Collaborate with cross-functional teams (e.g., R&D, Manufacturing, Supply Chain) to address customer complaints and improve customer satisfaction.
- Monitor and report on key quality metrics, providing insights and recommendations to senior management.
Required competencies: Education: - Master degree in Engineering, Quality Management, Life Sciences, or a related field.
Experience: - Minimum of 5-7 years of experience in quality management within the medical device industry.
- In-depth knowledge of ISO , FDA 21 CFR Part , and other relevant regulatory requirements.
- Proven experience in leading audits and managing CAPA processes.
- Experience in supporting quality aspects of the design and development process.
Skills: - Strong leadership and team management skills.
- Excellent problem-solving, analytical, and decision-making abilities.
- Effective communication skills, both written and verbal.
- Proficient in quality management tools and methodologies (e.g., Six Sigma, Lean).
- High attention to detail and commitment to maintaining high standards of quality.
