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Senior Quality Assurance Specialist
1 week ago
Cochlear, a leading medical device company, seeks an experienced Senior Quality Engineer to ensure regulatory compliance across the Quality Management System (QMS) and products. This role will provide ongoing support to Production and Engineering teams when potential quality issues are identified.
The ideal candidate will have a strong understanding of FDA 21 CFR Part 820 and EN ISO 13485 regulations, as well as experience with quality management tools and techniques. They will be responsible for identifying and implementing improvements to ensure Cochlear continues to effectively produce compliant products that satisfy customer, regulatory, and business requirements.
Key Responsibilities:
- Ensure regulatory compliance across the QMS and products by partnering with stakeholders, providing guidance, and training to meet FDA 21 CFR Part 820 and EN ISO 13485 regulations.
- Assist in identifying, evaluating, containing, investigating, and applying corrective actions for Class 3 Active Implantable Medical Devices.
- Support the Non-Conformance Report (NCR) process, conducting regular problem-solving meetings to provide direction and support for stakeholders.
Requirements:
- Bachelor's degree in Electrical or Mechanical Engineering or equivalent.
- At least 6 years of experience working in Quality or manufacturing operations in a regulated industry and 3 years of experience working as a Senior Quality Engineer.
- Strong knowledge of quality management tools and techniques, data analysis, metrics, reporting, and application of statistical methods.