Quality Systems Engineer

AliveDx; Penicuik; On-site; GBP 40,000 - 55,000; Full time

Benefits offered by this job

Private medical cover

Life assurance

Additional annual leave

Cycle to work

Marketplace discounts

Job summary

AliveDx is seeking a Quality Systems Engineer to join the Quality and Regulatory Affairs team at our ARC site near Penicuik, EH26 0BF. The role is full-time, 37.5 hours per week, focusing on document control, change control and failure investigations within an ISO 13485 and FDA 21 CFR Part 820 environment.

You will maintain QMS documentation, enforce version control, coach cross-functional teams in root cause analysis, and support external audits to ensure regulatory compliance across quality

Qualifications

• Bachelor's degree in a related field or equivalent experience.
• Minimum 3 years in document control or quality assurance in ISO 13485 GMP or 21CFR Part 820 environment.
• Experience with document management systems and electronic QMS.

Responsibilities

• Manage document control: creation, review, approval, distribution, retrieval.
• Oversee change control; log, evaluate and route engineering change requests.
• Lead change control board meetings and guide change.
• Manage product and process failure investigations and root cause analysis.
• Support external audits and regulatory compliance.

Skills

Document control

Quality assurance

Root cause analysis

Auditing

Education

Bachelor's degree in Quality Assurance, Life Sciences, Engineering or related

Tools

Document management system

Electronic quality management system

Job description

QUALITY SYSTEMS ENGINEER

AliveDx is recruiting for a Quality Systems Engineer to join the Quality and Regulatory Affairs team based at our ARC site near Penicuik, EH26 0BF.

The role is a full-time, permanent position working 37.5 working hours.

Job Purpose

Reporting to the Head of QMS, the Quality Systems Engineer is responsible for managing and overseeing three foundational QMS processes: document control, change control and failure investigations. This includes ensuring the proper creation, revision, approval, distribution, and archiving all quality-related documents, facilitating the change control process from end to end and applying root cause analysis methodologies to failure investigations. The role plays a critical part in ensuring that all processes meet regulatory, customer, and internal requirements within the medical device industry.

YOUR MISSION

• Manage the document control system, including document creation, review, approval, distribution, and retrieval processes, in compliance with ISO 13485 requirements.
• Ensure that all documents are maintained according to the company's quality management system (QMS).
• Establish and enforce version control to maintain accurate and up-to-date documents.
• Manage the change control process; receive, log, evaluate and route engineering change requests.
• Chair change control board meetings and guide change.
• Manage product and process failure investigations.
• Ensure root cause analysis methodologies are being used and coach cross-functionally to ensure competency in root cause analysis.
• Support external audits.
• Ensure that all documentation is maintained in compliance with ISO 13485, FDA 21 CFR Part 820, and other applicable regulatory requirements.
• Implement and maintain a secure system for archiving and retaining quality records according to regulatory and company retention policies.

YOUR COMPETENCIES

• Bachelor's degree in a related field (Quality Assurance, Life Sciences, Engineering) or equivalent experience.
• Minimum of 3 years of experience in a document control or quality assurance role within an ISO 13485 GMP or 21CFR part 820 -compliant environment, preferably in the medical device or pharmaceutical industry.
• Experience with document management systems and electronic quality management systems.

WHAT WE OFFER

• A highly dynamic and growing environment.
• An opportunity to live your passion for intrapreneurial mindset, where cultivating innovation and customer centricity are at the heart of everything we do.
• A flexible working environment where applicable and a range of core and flexible benefits ranging from private medical cover, life assurance, additional annual leave, cycle to work, technology and access to marketplace discounts.

AliveDx is an equal opportunity employer and welcomes applications from all qualified individuals regardless of nationality, sex, disability, region/belief, sexual orientation or age.

All aspects of employment including the decision to hire, promote, discipline, or discharge, will be based on competences, performance and business.