quality compliance officer

about us

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Thrive is on a mission to improve life through wearable technology. As the leading wearable technology agency, our team of experts innovate, design, develop and produce products globally. We are now looking for a quality compliance officer to join our growing team. We’re at an exciting stage in our growth, and if successful, you will play a pivotal role in ensuring Thrive maintains its position as the go-to wearable technology experts.

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why work at thrive?

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We work exclusively with clients in the health, wellbeing and fitness industries and we believe the work we do should have a positive impact on the world. We use our technical expertise to advise clients, (re)design their products, and build their roadmap for global-scale production. We not only solve our clients’ problems, we strive to exceed their expectations of research and design.

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As well as client work and partnership development, everyone at Thrive has the opportunity to instigate and work on our internal projects and innovations.

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We are a hybrid working company and our office in the heart of Brighton is surrounded by excellent shops, food options and pubs. We’re a close-knit and diverse team with a shared interest in technology, health and wellbeing.

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about the role

 

This role may be a part time or full time, what is important to Thrive is finding the right person for the role which we can mould around the best candidate.

 

We are looking for a Quality Compliance Engineer who has a thorough understanding of connected product design and delivery. The successful candidate will be the key person in the delivery and maintenance of our Quality Management System (QMS) supporting EN ISO 9001 and EN ISO13485.

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You will act and take accountability for the ‘Management Representative’ role within the QMS. 

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You will need to have great attention to detail, spotting gaps in the system and applying continuous improvement, risk mitigation and corrective actions, as well as ensuring that the team understands how and why to use the QMS across the business.

You will be an excellent communicator and provide high value input in the scoping and planning phase of potential projects, where assessment of relevant standards and associated costs and risks to Thrive may exist, such that we can propose realistic work packages to our client teams and provide layperson communication as needed to provide clear description of the value of areas of the QMS on the client’s projects.

 

As the Quality Compliance Engineer you will be proactive in developing our systems and processes further and finding ways to adjust and improve their use. You will be the key person responsible for Audits and will instigate and run internal Audits and improvement cycles. You will train the team in the QMS processes and ensure adherence to the policies.

 

We are looking for someone with passion for their work and in return we offer an environment that allows autonomy and space for a growing remit and the opportunity to train and manage a growing projects team, working on a wide range of technically complex client and internal wearable technology projects with the potential to have huge health and wellness impact globally.

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skills and experience

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Please consider the following as a guide. If you do not meet all of these points, do not assume you are not right for the role. We take a broad view of the people we hire and believe in training and development to fill gaps.

 

• Certified Auditor (lead or internal)

• Working with EN ISO 9001 and EN ISO 13485 Quality Management Systems

• Working with 21 CFR Part 820 / MDSAP

• Planning and running internal audits

• Being audited by Notified Bodies / FDA

• Building technical files

• Experience of Medical Device Standards - IEC 60601, ISO 14971, IEC 62304

• Training teams to the QMS

• Working with Agile and Lean methodologies

• Use of Jira / Confluence software

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accountabilities and responsibilities

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• Internal Audits

• Notified Body Liaison

• Management Reviews

• Quality Policy

• Quality Objectives

• Quality Management Training

• Ensuring QMS Processes are Documented

• Reporting QMS Effectiveness and Need for Improvement

• Promotion of Awareness of the QMS and Regulatory Requirements

• Ensuring QMS processes are delivering their Intended Outputs

• Keeping the company up to date in relevant standards and requirements 

• Assisting the team to record user inputs / outputs/ V&V / traceability 

• Assisting the team to provide systems engineering development for risk management

• Managing our projects medical device risk files where applicable

• Upkeep and adherence to our medical device software lifecycle process to IEC 62304

• Upkeep and adherence to our medical device risk management process to EN ISO 14971

• Upkeep and adherence to our medical device usability process to EN ISO 62366

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