I am working with a global Medical Device company that is growing out their Quality team. They are looking for a highly skilled and motivated Senior Quality Engineer to join our team and take on a pivotal role in overseeing Corrective and Preventive Actions (CAPAs) and production quality for Class III medical devices. The ideal candidate will bring extensive experience in quality engineering within an ISO 13485 environment, demonstrating a strong track record in managing complex quality issues and driving continuous improvement initiatives. This position offers a unique opportunity to influence quality strategies and ensure the highest standards of product integrity and regulatory compliance.
Key Responsibilities:
- Provide quality engineering support. Address product related issues arising in the manufacturing clean rooms and assure elements such as NCR, CAPA, audits and scrap are being used properly.
- Lead and manage the CAPA process from identification through investigation, implementation, and verification of effectiveness.
- Oversee quality activities related to production processes, including inspection, testing, and validation, ensuring compliance with ISO 13485 and FDA regulations.
- Collaborate with production teams to identify and resolve quality-related issues that impact product performance and safety.
- Conduct regular audits and inspections of production processes to ensure adherence to quality standards and regulatory requirements.
- Ensure all quality documentation, including CAPA records, deviations, and change controls, is accurately maintained and compliant with ISO 13485 and other applicable standards.
- Prepare and present quality reports, metrics, and performance indicators to management and regulatory bodies.
- Support internal and external audits, addressing any findings and implementing corrective actions as needed.
- Drive continuous improvement initiatives across the production and quality systems to enhance product quality and operational efficiency.
- Mentor and provide guidance to junior quality engineers and production staff on quality best practices and problem-solving techniques.
- Stay current with industry trends, regulatory changes, and advancements in medical device technology to ensure the organization remains compliant and competitive.
Qualifications:
Education:
- Bachelor’s degree in Engineering, Quality Assurance, Life Sciences, or a related field. Advanced degree or certification (e.g., CQE, Six Sigma) is a plus.
Experience:
- Minimum of 7 years of experience in quality engineering within the medical device industry, with at least 3 years focused on Class III medical devices.
- Proven experience managing CAPAs, production quality, and regulatory compliance in an ISO 13485 environment.
- In-depth knowledge of FDA regulations, ISO 13485 standards, and other relevant quality systems and regulatory requirements.
