Senior Quality Assurance Specialist

JR United Kingdom; Scotland; On-site; GBP 60,000 - 70,000; Full time

Job summary

A leading medical device manufacturer in West Lothian is seeking a Senior Quality Assurance Specialist to manage key elements of their Quality Management System. This role involves overseeing compliance, leading audits, and supporting continuous improvement projects as the company expands its product globally.

Qualifications

• Extensive experience in a QA role within a medical device, pharmaceutical, or related industry.
• Experience in an aseptic manufacturing environment is desirable.

Responsibilities

• Oversee the Material Review Board and disposition products.
• Participate in internal audits - process, product, and workplace audits.
• Manage Customer Complaint handling through to resolution.

Skills

Problem Solving

Job description

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Senior Quality Assurance Specialist, West Lothian

Client: Entrust Resource Solutions

Location: West Lothian

Job Category: Other

EU work permit required: Yes

Job Views: 8

Posted: 12.05.2025

Expiry Date: 26.06.2025

Job Description:

Senior Quality Assurance Engineer

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

Location: West Lothian

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 is a successful and rapidly growing medical device manufacturer. With a planned site expansion and approval for their product in the US within reach, they anticipate a significant 2025. The Quality Assurance Team is expanding to support this growth.

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

Further Key Responsibilities:

• Oversee the Material Review Board and disposition products
• Participate in internal audits - process, product, and workplace audits
• Generate and report quality KPIs to the Site Head
• Manage Customer Complaint handling through to resolution
• Perform post-market surveillance planning and reporting
• Provide expert guidance to technical and validation teams
• Support continuous improvement projects including change management and risk assessments
• Lead regulatory compliance projects, support gap analysis, and ensure closure of actions
• Assist during notified body audits and subsequent closure activities

Key Requirements:

• Extensive experience in a QA role within a medical device, pharmaceutical, or related industry
• Strong problem-solving skills
• Experience in an aseptic manufacturing environment is desirable
• Ability to manage multiple stakeholder groups from operators to executives