Senior Quality Assurance Specialist

Senior Quality Assurance Engineer

Base salary £60,000 - 70,000, plus additional bonuses

West Lothian area

We are seeking a highly experienced and skilled Quality Assurance Engineer to join a leading medical device business as they expand their product globally.

This role carries high responsibility, sitting directly beneath the site Head of QA.

The business are a successful and rapidly growing medical device manufacturer. With a planned site expansion coming up, and approval for their product in the US within touching distance, they have a huge 2025 ahead. After identifying several areas for growth in the business, the Quality Assurance Team are under going expansion to account for this.

As a brief synopsis, you will be responsible for managing key elements of the Quality Management System, Batch Release, and ensuring compliance to applicable standards across all levels of the business.

Further Key Responsibilities:

• Oversee the Material Review Board and disposition products
• A member of internal audit team - conducting process, product, and workplace audits
• Responsibility for generating and reporting of quality KPIs to Site Head
• Manage the Customer Complaint handling through to resolution
• Perform post-market surveillance planning and reporting
• Provide expert guidance and knowledge to technical and validation teams
• Provide quality guidance on continuous improvement projects including change management, and risk assessments
• Lead regulatory compliance projects, supporting gap analysis and action closure to ensure compliance to regulatory standards
• Provide support to management during notified body audits and subsequent closure

Key Requirements

• Extensive experience within a QA role within a medical device or pharmaceutical industry (experience with ISO 13485 required)
• Degree in scientific field or equivalent qualifications
• Strong problem-solving ability
• The ability to manage multiple stakeholder groups from operators to executive management

Apply now by hitting 'Easy Apply' or email for more information!