We are seeking a dedicated and experienced Quality Engineer to join our team in ensuring the highest quality standards for our implantable medical devices. As part of the quality assurance team, you will be responsible for maintaining compliance with regulatory standards, supporting product development, and ensuring the reliability and safety of our products throughout their lifecycle. Your role will be crucial in delivering safe and effective implantable devices that improve patient outcomes.
Key Responsibilities:
- Quality Systems Management:
- Ensure compliance with ISO 13485, FDA 21 CFR Part 820, and other applicable medical device regulations.
- Implement and maintain robust Quality Management Systems (QMS) for new and existing products.
- Lead internal and external audits, including supplier audits, and ensure corrective actions are implemented.
- Product Design & Development:
- Collaborate with cross-functional teams (R&D, manufacturing, regulatory, etc.) to ensure product designs meet quality and regulatory requirements.
- Provide input on Design for Manufacturing (DFM) and Design for Quality (DFQ) during the development of new implantable devices.
- Participate in design reviews, risk management activities (FMEA), and validation efforts.
- Validation & Testing:
- Develop and execute test protocols for product validation (IQ, OQ, PQ) and process validation.
- Review and approve test data to ensure consistency and compliance with quality standards.
- Support equipment and process validation, ensuring all processes are capable and under control.
- Risk Management & CAPA:
- Conduct risk assessments for implantable devices using ISO 14971, and actively participate in risk mitigation strategies.
- Lead investigations into product and process non-conformances, conducting root cause analysis and driving corrective and preventive actions (CAPA).
- Monitor trends in product performance and quality metrics, reporting findings to management and making recommendations for improvements.
- Supplier Quality Management:
- Collaborate with suppliers to ensure the quality of materials and components used in implantable devices.
- Develop supplier quality agreements, manage incoming inspections, and resolve quality issues with suppliers.
- Regulatory Compliance:
- Work closely with the Regulatory Affairs team to ensure all quality documentation supports regulatory submissions (FDA, CE Mark, etc.).
- Ensure that changes in design, materials, and processes comply with regulatory requirements through effective change control management.
- Continuous Improvement:
- Drive continuous improvement initiatives aimed at reducing defects, improving product quality, and enhancing manufacturing processes.
- Utilize quality tools such as Six Sigma, Lean, and Statistical Process Control (SPC) to optimize processes and reduce variability.
- Documentation & Reporting:
- Ensure accurate and detailed documentation of quality activities, including inspection reports, validation protocols, and non-conformance reports.
- Prepare quality reports and present findings to management and relevant stakeholders.
Qualifications:
- Education: Bachelor’s degree in Engineering (Mechanical, Biomedical, or related field).
- Experience: 3+ years of experience in a quality engineering role, preferably within the medical device industry.
- Regulatory Knowledge: Strong understanding of FDA regulations, ISO 13485, ISO 14971, and other relevant standards for implantable medical devices.
- Skills:
- Proficiency in quality tools (FMEA, root cause analysis, CAPA, SPC, etc.).
- Experience with product and process validation (IQ, OQ, PQ).
- Excellent problem-solving and analytical skills.
- Strong attention to detail and commitment to quality.
- Good communication skills and ability to work in cross-functional teams.
Preferred Qualifications:
- Certified Quality Engineer (CQE) or Six Sigma certification.
- Experience with implantable medical devices, such as pacemakers, stents, or orthopedic implants.
- Familiarity with cleanroom environments and sterile manufacturing processes.
