Senior Quality Assurance Specialist

Entrust Resource Solutions; Scotland; On-site; GBP 60,000 - 70,000; Full time

Job summary

An established industry player is seeking a Senior Quality Assurance Engineer to join their expanding team in the medical device sector. This pivotal role involves managing the Quality Management System, ensuring compliance with regulatory standards, and leading continuous improvement projects. As the company prepares for significant growth and product launches, your expertise will be crucial in maintaining high-quality standards and supporting audits. Join a forward-thinking organization where your contributions will directly impact their success in the global market.

Qualifications

• Extensive experience in QA within medical devices or pharmaceuticals.
• Ability to manage multiple stakeholders from operators to executives.

Responsibilities

• Oversee the Material Review Board and disposition products.
• Conduct internal audits and generate quality KPIs for management.

Skills

Problem-solving

Quality Management Systems

Regulatory Compliance

Stakeholder Management

Job description

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Finding Outstanding Talent in the Emerging Scientific Industry

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 Engineering.

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, pharmaceutical or closely related industry
• Strong problem-solving ability
• Previous experience working in an aseptic manufacturing facility desirable
• The ability to manage multiple stakeholder groups from operators to executive management

Apply now by hitting 'Easy Apply' or email [e-mail] for more information!

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance and Engineering

• Industries

  Biotechnology Research and Pharmaceutical Manufacturing

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