We are seeking a highly skilled and motivated Senior Quality Engineer to join our start-up medical device company based in Lake Forest, California. As a Senior Quality Engineer, you will play a crucial role in ensuring the quality, safety, and reliability of our medical devices, contributing to the improvement of healthcare worldwide.
- Design Control: Utilize your extensive design control experience to oversee and manage the quality aspects of product development processes. Collaborate with cross-functional teams to ensure compliance with regulatory requirements and industry standards during the design and development phases.
- Compliance and Regulatory: Stay up-to-date with relevant regulations and standards in the medical device industry. Lead efforts to ensure our products comply with all applicable requirements, including ISO 13485, FDA QSR, and other global regulations.
- Process Improvement: Apply your analytical and quantitative problem-solving approach to identify opportunities for process enhancements, efficiency improvements, and cost optimization. Drive continuous improvement initiatives to streamline quality-related processes.
- Risk Management: Conduct risk assessments and work closely with R&D and product teams to mitigate potential risks associated with product design and manufacturing. Develop and implement risk management strategies to maintain product safety and performance.
- Bachelor's degree or equivalent in Mechanical, Electrical, or Manufacturing Engineering.
- A minimum of 4 years of relevant industry experience in the medical device sector.
- Proven expertise in design control, ensuring compliance with applicable regulations and standards during product development.
- Solid understanding and application of quality tools and methodologies.
- Strong analytical and quantitative problem-solving skills, with a keen attention to detail.
- Excellent communication and interpersonal skills, enabling effective collaboration with cross-functional teams.
- Ability to work independently and as part of a team in a fast-paced, dynamic environment.
- Knowledge of ISO 13485, FDA QSR, and other relevant quality management system requirements.
Join our innovative and dedicated team, where your contributions will make a difference. We offer competitive compensation packages and opportunities for professional growth and development.