E&O Laboratories Ltd is a high growth, employee-owned trust Microbiology Culture Media manufacturer, based in Central Scotland with two GMP facilities and a donor animal farm. We are recruiting Production Operators for their facility at Westfield, Cumbernauld.

Job Opportunity:

Successful candidates will work in our fast moving, high energy environment learning how to operate automated and semi-automated production lines, where good hygiene and attention to detail are essential.

Due to the working environment this role does require the wearing of full PPE including bodysuits, hairnets, facemasks and foot coverings, to protect the product and prevent potential contamination.

About you

To be successful in this role you must be a highly motivated individual that can demonstrate flexibility with a can-do attitude. You should be positive, productive, and proactive with a passion for teamwork and problem solving.

The ideal candidates will enjoy working as part of a small team, as well as having good literacy & numeracy skills, previous experience of working within a production environment may be an advantage.

Shift Patterns:

Mon to Thu 18.00 to 22.00 (16 hours per week)

Mon to Thu 07.30 to 17.30 (40 hours per week)

Salary: £11.44 to £11.73 per hour

We are currently looking for an experienced Quality Assurance Assistant specialising in Regulatory Affairs to assist the Quality Manager with the Company’s regulatory compliance and processes, leading to timely product approval for both new and existing products.
This is an excellent opportunity for a person who enjoys working within quality management in a busy modern manufacturing environment.

Responsibilities:

• Demonstrate commitment to the development, implementation, and effectiveness of applicable Quality Processes as per ISO, IVD and other regulatory requirements.
• Act as Person responsible for regulatory compliance (PRRC) in accordance with article 15 of IVDR to ensure conformity of devices.
• Maintain regulatory databases ensuring product information is maintained.
• Take responsibility for promotion of Regulatory awareness and awareness of customer requirements across the business.
• Assist with regulatory, customer and third-party audits of the business.
• Assist with the CAPA process ensuring actions are completed in line with business deadlines.
• Ensure approved suppliers and external providers files are updated.
• Assist with continuous improvement with regard to risk management and post market surveillance.
• Assist with the QMS documentation requests both internal and external.
• Prepare internal and external reports and collate data.

Key Skills, Qualifications and Experience:

The successful candidate should hold the following qualifications and experience::

Bachelor’s Degree (or equivalent) in a related field with 1 years’ experience working within medical devices or IVD regulation or regulatory activities, or alternatively have 4 years’ experience working with medical devices or IVD regulation or regulatory activities.

In addition to this, the successful candidate should have:

• Knowledge of Quality Management systems, especially ISO 13485
• Be an experienced user of MS Office suite
• Have strong written and oral communication skills
• Excellent social, communication and organisational skills
• Enjoy working as part of a team in a non-corporate environment

To apply please email your CV and your salary expectations to hr@eolabs.com