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Quality Systems Manager

Experience Dependant
Job Reference: J5631621
Updated On: 04/06/2019
Status: Open to Applications
Hyper Recruitment Solutions
Sectors: Pharmaceutical, Biotechnology, Medical Device

Skills: Quality Assurance - Permanent, Quality Assurance - GMP, Quality Assurance - ISO13485, Quality Assurance - Compliance, Quality Assurance - Auditing, Quality Assurance - ISO9001, Quality Assurance - Quality Manager

Job Information

Role Overview

We are currently looking for a Quality Systems Manager to join an exciting, early stage, Medical Device company based in the Surrey area. As the Quality Systems Manager you will be responsible for developing the Quality strategy, Processes and Systems to the relevant regulatory standards.

Key Duties and Responsibilities

Your duties as the Quality Systems Manager will be varied however the key duties and responsibilities are as follows:

1. You will work with the wider business to establish the Quality strategy, advising on regulatory compliance to ensure the business can meet the expectations of achieving successful ISO13485 and FDA510K registration.

2. You will be tasked with the development of site wide Quality projects, with the aim of ensuring continued compliance against the Quality System. This will include conducting audits and detailing audit reports to the Senior Management Team.

3. As the Quality Systems Manager you will work closely with the Senior Management Team to develop, implement and manage a set of KPI and Milestone targets to achieve a successful ISO13485 and FDA510k registration.

4. You will work very closely with internal and external partners, including regulatory bodies and will act as the main point of contact. Therefore a thorough understanding of a compliant ISO13485 Quality System is essential.

Role Requirements

To be successful in your application to this exciting opportunity as the Quality Systems Manager we are looking to identify the following on your profile and past history:

1. You will have previously managed a compliant ISO13485 system. It would be advantageous if you have previously implemented a compliant ISO1485 from design to registration, or have developed an ISO13485 system to new regulations.

2. Previous experience managing a Quality function within a pharmaceutical or medical device company. The opportunity will work cross collaboratively and will hold a senior title within the business. Therefore experience working at an Operational level is a must.

3. An understanding or experience of working within a sterile manufacturing environment would be advantageous.

Key Words: Quality Systems | Quality Manager | QMS | Operational | Medical Device | Pharma | Sterile | Bio | ISO13485 | 13485 | FDA | MHRA | Sterility | Quality Assurance
Chris Carey
Your Recruitment ConsultantChris Careychris.carey@hyperec.com
DisclaimerHyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for our talent development. We welcome applications for any applicant who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment processionals and scientists. We look forward to helping you with your next career moves.