Quality Systems Manager (Medical) - Coleraine or Comber

VanRath; Northern Ireland; On-site; GBP 40,000 - 80,000; Full time

Job summary

An established industry player in healthcare is seeking a Quality Systems Manager to enhance their Quality Assurance strategy. This pivotal role involves leading quality compliance efforts and ensuring adherence to ISO standards and FDA regulations. The position offers a fantastic opportunity to work with a top-tier organization known for its commitment to excellence. You will be responsible for chairing the Group Change Control Program, supporting new product development, and conducting audits. If you have a strong background in quality engineering and a passion for continuous improvement, this role is perfect for you.

Qualifications

• Significant experience in a Quality Engineer role required.
• Quality Compliance experience in a customer-driven environment.

Responsibilities

• Chair and facilitate the Group Change Control Program.
• Lead and represent at external agency and customer inspections.
• Develop and implement a system for imbedding QA culture.

Skills

Quality Assurance

Quality Compliance

Communication Skills

Organizational Skills

Education

Experience in Quality Engineer role

Experience in Medical Device or IVD environment

Job description

VANRATH are delighted to be assisting a global leader in Healthcare / Medical with the recruitment of a Quality Systems Manager. Fantastic company to work in.

Office is based in either Coleraine or Comber - Monday to Friday

Initially a 12-month contract

This is an Amazing company that has a top reputation.

Salary:

Negotiable + Bonus & Fantastic Benefits

About the Role:

The Quality System Manager plays a key role in the success of EHG's Quality Strategy, ensuring the development and implementation of the Quality Assurance strategy while reporting on all aspects of the role.

Key Responsibilities:

1. Chair and facilitate the Group Change Control Program, in line with business procedural requirements.
2. Support New Product Development activities as required.
3. Lead & Professionally represent at all external agency & customer inspections.
4. In conjunction with the Quality & Regulatory Department, provide input, support and collaborative decisions regarding the execution of any Field Safety Corrective Actions (FSCA) in a timely, thorough and transparent manner.
5. Deliver relevant Internal quality assurance training for departments.
6. As a member of the Group Operations Compliance Team, develop and implement a system for imbedding QA culture through the UK Businesses.
7. Responsible for ensuring the Quality Management System is maintained to deliver compliance and aligns with assigned KPI.
8. Support both the Internal and Supplier audit schedule, conducting Inspections when assigned.
9. Work on cross functional teams providing input when required.
10. Contribute to budget preparations in conjunction with Head of Group Operations Compliance.
11. Ensure that all assigned budgets are monitored and delivered.
12. Measure and trend Documentation and Change Control Programs against agreed.

Key Attributes:

1. Significant experience in a Quality Engineer role.
2. Quality Compliance experience in a Medical Device customer driven environment.
3. Experience in Medical Device or IVD environment working to ISO Standards and FDA CFR in a continuous improvement environment.
4. Significantly strong communication skills, both verbal and written.
5. An organised individual who has the ability to assess priorities based upon the wider business demands.

For more information or to apply, please use the link provided or contact Jack Groves.