Principal Engineer, Quality Assurance
4 days ago
Edwards Lifesciences is seeking a highly skilled Principal Quality Assurance Engineer to join our team. As a Principal Quality Assurance Engineer, you will be responsible for ensuring the quality of our medical devices and ensuring compliance with regulatory requirements.
Key Responsibilities- Develop and implement quality assurance processes and procedures to ensure compliance with regulatory requirements.
- Conduct audits and assessments to identify areas for improvement and implement corrective actions.
- Collaborate with cross-functional teams to ensure quality is integrated into all aspects of product development and manufacturing.
- Develop and maintain technical documentation, including quality procedures, work instructions, and training materials.
- Provide training and guidance to colleagues on quality assurance processes and procedures.
- Bachelor's degree in a relevant field, such as engineering or life sciences.
- Minimum 6 years of experience in quality assurance, with a focus on medical devices.
- Proven experience in developing and implementing quality assurance processes and procedures.
- Strong knowledge of regulatory requirements, including FDA 21 CFR 820 and ISO 13485.
- Excellent communication and interpersonal skills.
- Master's degree in a relevant field.
- Experience with quality management systems, such as ISO 13485.
- Knowledge of statistical process control and quality metrics.
- Experience with training and development programs.
Edwards Lifesciences offers a competitive salary and benefits package, including medical, dental, and vision insurance, 401(k) matching, and paid time off.
We are an equal opportunity employer and welcome applications from diverse candidates.
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