Quality Team Leader Leeds, England
Job description
About us
For over 30 years, Surgical Innovations have proudly designed, developed and manufactured high quality, precision engineered instruments for minimally invasive surgery and are a leading UK manufacturer of medical devices in its respective field.
Our success is our people and we currently employ over 100 staff from our head office in Leeds. We place great value on our mutually respective relationships, a workplace which is collaborative and dynamic, and a culture which is inclusive and purposeful. The result; a platform for individual development, growth, and prosperity.
As we seek to identify, nurture, and retain talent, we offer competitive benefits packages, continuous training and development opportunities to ensure those joining us on our journey, grow too!
Do you want to be part of an organisation that is leading the evolution in delivering sustainable and innovate solutions which advance healthcare? If so, we want to hear from committed and talented people like you, who share our vision and values to come and join our team.
About the Position
An opportunity has become available for a Team Leader working in the Quality Assurance Department.
As Quality Team Leader you will be responsible for the day-to-day management of the Quality System and the prioritising of departmental activities to meet planned demands. This role will work collaboratively with the Manufacturing, Quality Control and Purchasing teams within the business to ensure product is released on time and to the correct standards..
You will be a self-motivated, self-starter that is able to work under your own initiative, whilst also working to tight deadlines
Responsibilities
On a day to day basis your new role will involve:
- Manage & develop the QA team to ensure all compliance requirements are met and adequate cover is maintained.
- Day-to-day management of QMS (document control, change control, CAPA/NCR, concessions, supplier control, customer complaints)
- Management of all environmental, microbiology and routine product sterilisation / validation activities to ensure these are completed to schedule.
- Prioritise workloads and throughput to meet business demands
- Facilitate and uphold the correct application and completion of all quality documentation generated through the business.
- Manage final batch release process to meet sales demands
- Troubleshoot and resolves quality related internal enquires, and issues within the business
- Participate in external third-party audits acting as QMS SME.
- Complete trend analysis, reporting and presenting of Quality data at all levels and specifically for management review.
- Support the maintenance and development of the QMS to reach compliance with current standards and regulations.
- Carry out and ensure Internal audit are completed to schedule.
- Develop, improve, and write new processes and SOPs as required
- Lead on assigned projects to improve quality/regulatory compliance.
- Manage distribution quality issues with key stakeholders to ensure timely resolution.
- Review and approval of NPD related documentation
- Assist with regulatory activities where required.
- Provide QMS related training to support and improve compliance to current standards and regulations.
- Ensure a full set of training records are available for the team and these and the training matrix are kept up to date
Requirements
To be successful in this role you will need to be able to demonstrate the qualifications, experience and skills for the role:
- Working Knowledge of EU Medical Device Regulation, MDSAP country specific regulations including, FDA regulations (21 CFR 820), Canadian Medical Device Regulations and other international regulations.
- Minimum 3 years’ experience in Quality Assurance, working to the requirements for international quality systems for a medical device company, including ISO 13485.
- Minimum 2 years’ experience in leading a team.
- Excellent communicator and able to collaborate effectively with others.
- Strong organisational skills with a keen eye for detail.
What we offer
This position offers a competitive salary of up to £35,000 (negotiable), accompanied by a range of benefits including flexi time, pension, life assurance, income protection, health cash plan, perkbox, and bonus scheme.
Surgical Innovations is also currently trialling a 4 day working week, less hours for the same pay, as part of our employee initiatives.
If this sounds interesting and the right challenge for you, we look forward to receiving your application!
Job Types: Full-time, Part-time, Permanent
Part-time hours: 34 per week
Salary: £35,000.00-£38,000.00 per year
Benefits:
- Flexitime
Schedule:
- Flexitime
Supplemental pay types:
- Bonus scheme
Ability to commute/relocate:
- Leeds: reliably commute or plan to relocate before starting work (required)
Work authorisation:
- United Kingdom (required)
Work Location: One location
Reference ID: SIQA01
Expected start date: 06/03/2023
