We are seeking an experienced and motivated Quality Engineer II to join a dynamic team within the my client in the medical device industry. This role focuses on maintaining the highest standards of quality and regulatory compliance, working in a fast-paced manufacturing environment, including ISO Class 8 cleanroom operations. The successful candidate will be responsible for supporting the company's quality initiatives and ensuring adherence to industry standards.
Key Responsibilities:
- Develop and maintain documentation in line with FDA, ISO, and MDR requirements.
- Actively contribute to the documentation control process.
- Review, approve, and release final product documentation.
- Initiate and approve Non-Conformance Reports, leading root cause analysis investigations.
- Participate in and lead risk analysis initiatives, including FMEA.
- Initiate and approve temporary deviations.
- Implement effective corrective and preventive actions (CAPA).
- Support the environmental monitoring process.
- Represent the quality team as part of the Material Review Board.
- Review and approve validation protocols and reports (IQ, OQ, PQ).
- Manage engineering change notices and customer complaints, including replies.
- Support regulatory, notified body, and customer audits.
- Perform internal audits and contribute to ongoing compliance.
- Collate and analyse key performance data on a monthly basis.
- Actively participate in management reviews and compliance meetings.
- Collaborate with cross-functional production teams to achieve common goals.
- Perform additional duties as required.
Qualifications and Experience:
- Degree in Manufacturing Engineering, Quality Engineering, Life Sciences, or a related field.
- Minimum of 3 years of experience in a Quality Engineer role within the medical device industry.
- Strong communication skills, a team-oriented approach, and the ability to work autonomously.
- Experience with lean manufacturing tools and techniques is advantageous.
- Quality and auditor certifications are a plus but not mandatory.
This is a fantastic opportunity to further develop your career in quality engineering within the medical device sector. If you're a proactive problem-solver with a passion for maintaining high standards, we’d love to hear from you!