With accelerating growth and increasing levels of activity, the company is now looking for a Quality Assurance & Regulatory Compliance (QARC) Engineer. This is an opportunity to directly report to and support the QARC Manager in executing the quality and regulatory strategy.
What you will do?
As the job title suggests, the role extends across quality and regulatory compliance aspects of the business, both being key to the field in which the company operates. We aspire to high standards of quality, which our customers also expect and require of us. We have long held ISO 13485 and ISO 9001 certification and are currently pursuing ISO 27001 as well. From a regulatory compliance perspective, we work in an industry in which our products and services affect the way in which patients are diagnosed and treated. We therefore maintain stringent control over both our own and our partners’ products from their initial assessment, and careful marketing to their oversight in day-to-day customer use.
Execute Core Quality Assurance and Regulatory Compliance Activities
- Lead the project for the implementation of a new eQMS software
- Execute eQMS administration functions
- Manage Corrective and Preventive actions including complaint activities
- Support the business in incident management, investigation and root cause analysis
- Supervise the document and change control activities
- Manage record retention
- Coordinate training activities to ensure sufficient records are maintained
- Prepare, conduct and report internal audits
- Prepare, host and manage external audits and inspections including all follow up activities
- Prepare, conduct and report supplier assessments and performance reviews
- Collate and analyse quality data trends for input to the Quality Management System Review
- Conduct management system & regulatory induction / training
Support product portfolio regulatory compliance
- Maintain regulatory coverage status of product portfolio.
- Maintain relationships with clinical application regulatory counterparts.
Championing the quality agenda
- Ensure ongoing compliance to ISO 9001, ISO 13485 and other external standards as required
- Support the collation of Technical Files (Design History Files, etc.)
- Support team with hazard management
- Support team with project retrospectives
For this role the successful candidate will demonstrate the following knowledge, experience, skills and attributes :
- A solid background and experience in working in comparable roles, ideally in a medical device or software-based environment.
- Familiarity with relevant regulations:
- FDA 510(k); 21 CFR part 820
- Medical Device Directive (MDD)
- Medical Device Regulation (MDR)
- Experience of executing activities within a quality management system.
- Familiarity with relevant standards and guides, including:
- BS EN ISO 13485 Medical Device QMS Requirements
- BS EN ISO 62304 Medical Devices Software Lifecycle Processes
- BS EN ISO 14971 Application of Risk Management to Medical Devices
- BS EN ISO/IEC 27001 Information Security Management Systems; cybersecurity
- BS EN ISO 9001 Quality Management System Requirements
- Experience of operating across multiple functions in a high growth, fast-paced environment.
- Willingness and confidence in championing quality and compliance standards.
- Excellent communication skills, both verbal and written – accuracy and attention to detail are key.
- Ability to work both on your own and as part of a team.
- Excellent planning and organisational skills having the ability to prioritise and escalate tasks as appropriate.
- Clearly demonstrate the ability to take ownership of and complete tasks independently.
- Ability to meet deadlines and maintain high standards even when under pressure.
- Comfortable with working flexible hours and occasional travel when required.