Senior Quality Assurance Specialist
5 days ago
Company Overview
">FRS Recruitment is a leading contract manufacturer of medical devices serving global healthcare companies.
">About the Role
">As a Quality Engineer, you will play a key role in ensuring the highest quality standards are met across production processes.
">Key Responsibilities:
">- ">
- Provide ongoing quality support to maximise production performance and product integrity.">
- Lead investigations into quality issues, identify root causes, and implement corrective actions.">
- Ensure compliance with ISO 13485, ISO 14971, and FDA QSR 21 CFR Part 820 standards.">
- Develop and maintain quality management systems, inspection plans, and risk assessments.">
- Perform internal and external audits, including customer and regulatory body inspections.">
- Support new product introduction (NPI) with process validations and documentation.">
- Oversee non-conforming materials, CAPA investigations, and customer complaints.">
- Train and mentor junior engineers, promoting a culture of continuous improvement.">
Requirements:
">- ">
- Education: Level 8 Degree in Engineering.">
- Experience: Minimum three years' experience in a Quality Engineering role, preferably in medical devices.">
- Skills: Strong problem-solving and data analysis skills.">
- Ability to work cross-functionally in a fast-paced manufacturing environment.">
- Excellent communication and interpersonal skills.">
- Proficiency in Microsoft Office, with knowledge of Minitab and Syspro being an advantage.">
- Strong understanding of GMP, validation, and regulatory standards.">
Benefits:
">- ">
- Negotiable">
- Healthcare Pension">
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