Senior Medical Device Test Technician (GMP/GLP) in Loughborough

At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.

The Impact You Will Make:

Our Medical Device Testing Technician sits within the Kindeva Outsourced Manufacturing Team, supporting the commercialized IDD Devices providing basic technical / non-technical support to outsourced partners, customers, and internal colleagues for the main device. The main device is the integrated dose counter/ dose indicator inserted into an actuator to deliver inhaled respiratory medication. You will support the testing and documentation associated with changes, customer requests and equipment installation/validation, ensuring best practices are followed. All activities must meet internal and external standards for health, safety, legal, HR, regulatory, and quality compliance.

We are looking for an experienced detailed-driven, hands-on testing technician to play a key role in ensuring the safety, quality and performance of our medical devices. Working within a regulatory laboratory environment carrying out functional testing, ensuring every product meets industry standards.

Are you someone who has hands-on experience in Device Functional testing with the ability to write technical documents?

Key Responsibilities include, but are not limited to:

• Perform testing of IDD devices using SOPs and protocols.
• Operate equipment following standard operating procedures (SOPs) and troubleshoot basic issues.
• Author documentation such as protocols, reports and change controls and process them through our document management system.
• Responsible for understanding the full scope of assigned tasks, ensuring they are completed On Time, In Full, On Budget (OTIFOB).
• Communicate issues/delays to key stakeholders and ensure all data delivered is accurate, compliant, and appropriately reviewed.
• Become a competent user of Kindeva’s document management system.
• Maintain accurate records according to GMP, including daily logs and equipment tracking documentation.
• Support problem resolution by analysing data and recommending corrective actions.
• Develop a working knowledge of relevant subject matter, including the devices, outsourced partners and customers.
• Following training performs work independently with minimal supervision.
• Escalate complex issues to senior staff or technical leads.

Skills & Experience:

• 5+ Years experience working within medical device functional testing department, in a pharmaceutical or medical device product testing environment.
• Knowledge of industry standards and regulations such as GMP/GLP and medical device testing standards.
• Detail-oriented and analytical thinker able to quickly detect issues, fix discrepancies and propose solutions.
• Experience with report writing, planning and documentation.
• Computer literate, familiar with Microsoft Word and Excel.
• Degree in a Science, Engineering, or related field.
• Familiarity with basic statistics and experimental design.

Key Capabilities:

• Good organisational, interpersonal, and time management skills.
• Enthusiastic, flexible, conscientious and proactive in approach.
• Good decision making and problem-solving skills.
• Strong verbal, written and numerical aptitude skills.
• Strong team player with the ability to work independently.
• Adapt to changing priorities and timelines, without compromising on quality.
• Maintain a high standard of accuracy, completeness, and documentation.
• Champion data integrity and a right first-time culture.

What we Offer:

• Attractive compensation package.
• Company pension scheme (up to 10% employer contribution).
• 25 days holiday per year (plus bank holidays) plus service days after 5 years.
• Private Medical Insurance.
• Company sick pay.
• Employee Assistance Program with 24/7 confidential helpline support for employee and immediate family.
• Life assurance of four times life cover salary.
• Wellness programmes.
• Employee recognition program.
• Free on-site parking.
• Discount and cashback at many retailers.
• Cycle to work scheme.

Additional Information:

Location: Charnwood Campus, Loughborough. All applicants must be eligible to work in the UK. We believe our people make the difference at Kindeva, we look for skilled, passionate, and driven professionals to come and work with us to help us excel in manufacturing technologies and processes, which bring lifesaving products to patients worldwide.