IDS is a leading in-vitro diagnostic solution provider to the clinical laboratory market. We develop, manufacture and market innovative immunoassays and automated immunoanalyser technologies to provide improved diagnostic outcomes for patients.
IDS Boldon is the global IDS Headquarters occupying a single, multi-disciplined site.
The site focuses on the manufacture and distribution of manual Immunoassay products. On site Purchasing, Logistics, Production, Quality Control and Process Development departments manage the supply chain, supported by local Sales Support, Quality Assurance, Regulatory Affairs and Finance departments. As Group Headquarters, IDS Boldon also houses all head office functions.
Are you passionate about ensuring that innovative in vitro diagnostic (IVD) products meet the highest standards of quality and compliance? We are seeking a proactive individual to champion our Quality Management System (QMS) and Regulatory Affairs efforts, ensuring seamless manufacturing, distribution, and regulatory approval processes.
Principal Accountabilities
• Assist in the management of all the QA aspects of Quality Compliance for the manufacture of IVD products.
• The review of manufacturing batch records and the QA disposition of final products.
• Interface with R&D and Operations departments to ensure the efficient and compliant transfer of new products from R&D to production.
• Ensure that products and processes comply with the relevant requirements of the quality management system.
• Evaluate and enhance Quality Systems to ensure that products and processes meet defined quality standards and comply with the appropriate international standards and regulations.
• Facilitation of root cause analysis and implementation of effective CAPA for process related concerns.
• Assessment of change to ensure quality impact analysis, risk management and validation activities are identified and carried out.
• Deliver training to build quality awareness
• Conduct internal Quality audits.
• Assist in the investigation and analysis of failure, corrective and preventive action to respond to customer complaints. Including assessment of potential reportable events.
• Assist in the creation and maintenance of company quality documentation, such as quality manuals, quality procedures, etc.
• Preparation of QMS documentation; SOPs, QA reports etc.
Support the Regulatory Affairs team with:
• The creation and maintenance of Technical files for the IVD Directive/Regulation
• Preparation of regulatory submissions for countries of interest that implement marketing regulations.
• Manage and maintain IVD Device registrations.
• Review all labelling, marketing and training materials for regulatory compliance.
Skills, Knowledge and Experience
Qualifications
• Bachelors degree (or equivalent) in Biochemistry or similar (OR at least 2-3 years relevant experience)
• Internal Auditor ISO 9001 or ISO13485
Skills & Knowledge
• Knowledge of, and experience in the application of, ISO 13485, IVDD, CMDR and IVDD
• Good attention to detail; and communication skills both internal and external
• Ability to work as part of a team, departmentally and inter-departmentally
• Ability to work under pressure and to strict deadlines
• Ability to work in an autonomous, self-managed role.
• Good organization and influencing skills
Desirable
• Knowledge or experience in Regulatory Affairs
Experience
• At least 2 years experience in a QA/QC or Production role within IVD, medical device or other healthcare industry.
• Experience of applicable regulations for manufacture and distribution of devices in EU, US and Canada.
• Knowledge of Quality Systems and their operation
Our Values
- Embrace the unknown - every big idea starts with a bold, fundamental question: What If?
- Passion for people - our people are our greatest asset and fuel our success in service of humanity.
- Collaborate for success - we put team before self to achieve the unexpected with transparency, accountability and integrity.
- Partner with purpose - we inspire new paths with customers to accelerate positive outcomes.
Benefits
We truly value our people and provide a mix of benefits as well as providing an environment where our employees’ career and wellbeing can flourish.
Here is a taster of what we offer:
• 25 days holiday + bank holidays. In addition, we offer a holiday purchase scheme where employees can purchase a further 5 days.
• Enhanced private company pension, IDS contribute up to 5% of your annual salary.
• Should you wish to opt into private healthcare, IDS will pay 50% of your healthcare cover for either single or family plans.
• Access to our Employee Assistance Platform, providing you and your family with access to wellbeing resources and therapy, as well as retailer discounts.
• Life insurance at 2x your annual salary.
• Hybrid working, consisting of a 3:2 ratio / 3 office days and 2 home days per week which is available in all roles where it is practical to do so.
• Sports and social club - a subsidised membership scheme offering four fun activities each year (go-karting, abseiling, meals out, comedy club, cinema etc)
• Free on-site parking
•Discretionary annual bonus
• Complementary tea, coffee, fruit and season treats
We are committed to supporting your career development and offer a number of incentives and rewards to recognise your contributions:
o Reward of £500 for successfully referring a friend to IDS
o Living our values award recognises and rewards those who demonstrate exemplary behaviours which support our core values.
o All ideas matter award encourages and rewards employees to be creative and put forward new ideas. Successful ideas are generously rewarded.
Diversity, equality and inclusion is really important to us and we are committed to creating a culture where everyone feels that they can truly be themselves and bring their own originality, creativity and identity to IDS.
