Change Control Team Leader

Change Control Team Leader

Job Title: Change Control Team Leader
Contract Type: Permanent
Location: Dunfermline
Salary: Up to £35,000
Start Date: 2017-12-18
Reference: 15702+JM
Contact Name: Julie McEwan
Contact Email:
Job Published: December 18, 2017 14:36

Job Description

Do you have experience with quality management systems from within a medical device or manufacturing environment?  Do you have expertise in ISO13485/9001 accreditation or device master record traceability for audit purposes?  Are you looking for a new challenge for 2018 and want to work with a company that believe their employees are their most valuable assets?

The Role

As an integral member of the Quality Assurance department you will be responsible for overseeing and documenting the complete product change cycle for a portfolio of innovative retinal imaging devices, to ensure they consistently meet the requirements and specifications for cGMP. This role will be fast paced and require excellent organisational and problem solving skills alongside the ability to communicate efficiently with a variety of internal and external stakeholders. The role would be ideal for someone that has an analytical viewpoint and is flexible in their approach, as the successful candidate will be required to consistently assess performance/procedures and will always be looking for ways to improve existing processes. Responsible for the QMS documentation and software you will report directly to the Director of Quality Assurance and play a central role in ensuring that quality output and change control metrics are beyond repute.

As the Team Leader you will be responsible for mentoring a small team across document control and design and product change control and coordination.

The Company
A growing medical device company, operating on a global platform that specialises in the diagnosis, treatment and prevention of retinal diseases and disorders. With over 25 years’ experience within this sector to draw upon they are at the forefront of innovation.  Placing high importance on work/life balance the company believe that professional and personal goals are of equal importance and provide an environment where both can be realised. A competitive salary and extensive benefits package are offered complementing a friendly and supportive company environment and valued employee ethos.

A competitive salary is offered backed by an extensive benefits package including 34 days annual leave (including bank holidays), company bonus, contributory pension, flexi-time, private health care and insurance schemes.  The company believe their employees are their most valuable asset.

You will need to have previous experience of working within a quality department, ideally with medical devices and ISO13485 accreditation, however experience within ISO9001 from a volume manufacturing environment will also be considered. The successful candidate will be pragmatic in their approach and have the ability to negotiate and influence others, alongside commercial awareness of the FDA regulations surrounding medical device manufacture. You will also be able to demonstrate that you can excel in a time sensitive environment and lead a team successfully.