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.
We are an ISO9001/ISO13485 manufacturer of regulatory-cleared medical device software, with all that that entails from a QA and regulatory perspective. But we are also a “reseller” of a growing portfolio of 3rd party clinical applications with a need to ensure we represent and support those products in line with their regulatory clearance. As we also integrate these applications onto our Platform we need to ensure, with our partners, that these integrations do not cross any regulatory boundaries, and are of appropriate quality in general.
The field we operate in, and our needs, are constantly changing:
- Our portfolio currently contains around 45 third party clinical applications and could double in size over the next 2 years.
- Although focused on US today, our partnerships are taking us into international markets so we care about regulatory regimes across the globe.
- AI-based imaging software itself is at a very early stage and its regulation will continue to evolve as new products arrive and the various regulatory bodies catch-up with the rapid progress of this tech
All of this means there is both a ‘traditional’ quality and regulatory role to fulfil for Blackford’s own products, but also the challenge of creating a scalable way to manage the challenges around the increasing number of 3rd party applications and markets we want to address.
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.
Quality and Regulatory Compliance aren’t administrative functions at Blackford – they are core to what we do, and you will be directly involved in critical business activities as a result.
Key responsibilities will include:
- Execute Core Quality Assurance and Regulatory Compliance Activities
- 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
Blackford are keen to hire people that share their vision and excitement about the development of their business, and who want to play an important role in helping them achieve its full potential. Candidates must bring energy, self-motivation and have a pro-active and flexible approach.
Required Knowledge / Experience
- 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.
Key Personal Criteria:
- 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.
At Blackford, we are proud of our diverse and fully inclusive culture and we don’t tolerate any kind of bias, judgement or harassment. We want our recruitment process to be accessible to everyone so if you require any reasonable adjustments please note them on your application and we’ll do our best to accommodate your request.