As the new Quality Engineer, you will take ownership of assigned areas of the QMS, driving improvements, maintaining compliance with ISO 13485 and ISO 14001, and supporting the QA/RA team and wider business on quality-related matters.
To be successful as the new Quality Engineer, you will have proven experience in Quality Assurance in highly regulated manufacturing, a strong understanding of ISO standards, expertise in using quality investigational tools, and experience conducting internal and supplier audits.
Key Responsibilities
Supporting quality-driven, technology-focused projects Developing and updating QMS procedures and associated documentation Conducting internal and supplier audits Managing and implementing CAPAs Performing gap analyses for standards and regulations Supporting product risk assessments Driving continuous improvement projects with a focus on sustainability Providing QA support for new product development and design changes
Minimum Requirements
Proven experience in a Quality Assurance role within a highly regulated manufacturing environment Knowledge of ISO standards i.e. 9001, 13485, 9100, 16949 Experience with CAPAs, risk management and quality investigational tools Certified Internal Auditor Ability to work independently on key projects and mentor team members Strong communication and problem-solving skills, with the ability to influence stakeholders
If you're looking for an exciting opportunity to be part of an established, market leading Medical Device company, get in touch now.
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