Katalyst Healthcares and Life Sciences
Responsibilities:
- Ensure compliance with ISO 13485, FDA 21 CFR Part 820, and other medical device regulations.
- Implement and maintain robust Quality Management Systems (QMS) for both new and existing products.
- Lead internal and external audits, including supplier audits, and oversee corrective actions.
- Collaborate with cross-functional teams (R&D, manufacturing, regulatory) to meet quality and regulatory requirements in product designs.
- Provide input on Design for Manufacturing (DFM) and Design for Quality (DFQ) during development of implantable devices.
- Develop and execute test protocols for product (IQ, OQ, PQ) and process validation.
- Conduct risk assessments for implantable devices using ISO 14971 and participate in risk mitigation strategies.
- Lead investigations into non-conformances, performing root cause analysis and driving corrective and preventive actions (CAPA).
- Collaborate with suppliers to ensure quality of materials and components and develop supplier quality agreements.
- Drive continuous improvement initiatives using quality tools like Six Sigma, Lean, and Statistical Process Control (SPC) to enhance product quality and manufacturing processes.
- Bachelor's degree in engineering (Mechanical, Biomedical, or related field).
- 3+ years of experience in a quality engineering role, preferably within the medical device industry.
- Strong understanding of FDA regulations, ISO 13485, ISO 14971, and other relevant standards for implantable medical devices.
- 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.
- Certified Quality Engineer (CQE) or Six Sigma certification.
- Experience with implantable medical devices, such as pacemakers, stents, or orthopaedic implants.
- Familiarity with cleanroom environments and sterile manufacturing processes.