Quality Manager

2 weeks ago

Hertfordshire, United Kingdom Reed Scientific Full time

REED are working with a leading medical device manufacturer based in the Hertfordshire area to fill a vacancy for a **Quality Assurance/Regulatory Affairs Manager**. The company manufactures and supplies a number of Class I, IIA and IIB medical devices within the Suction, Oxygen Therapy market to UK Hospitals and Distributors worldwide.

**About the Job**
- Maintaining compliance to ISO 13485:2016
- Be part of the management team & provide Quality and Regulatory advice to senior decision makers.
- Maintaining an audit ready site.
- Supporting quality system design and implementation - including CAPA, Non-Conformance, Change Controls etc.
- Perform the role of Management Representative.
- Perform the role Person Responsible for Regulatory Compliance (PRRC)
- Lead all communication with regulatory authorities and Notified Bodies.
- Maintain a detailed knowledge of regulatory requirements.
- Conducting Internal Audits.
- Support the CE Marking and UKCA Marking submission process.
- Perform all Post Market Surveillance activities.
- Management of vigilance and incident reporting system and processes.
- Ensure compliance with EU Directive 93/42/EEC (as amended) and EU 2017/745
MDR and UK MDR 2002.
- Promote a culture of compliance to regulations, standards, procedures and risk
management.
- Prepare quality and regulatory reports for internal, regulatory and customer use.
- Management of GS1 Number Bank and UDI labelling for the devices.
- Management of Infrastructure and Calibration Activities.
- Management of all health and safety business compliance conformity.

**Requirements**:

- Excellent understanding of the requirements of ISO 13485, Risk Management and
CE Marking directives/regulations and UKCA Marking for all products.
- Experience with active Class IIa and IIb Medical Devices

**About You**
- Bachelor Degree in Engineering/Science or Business-related field or 5 Years’ experience within the Medical Devices industry.
- Ability to multi-task and work well under pressure within a small team.
- Qualified ISO 13485:2016 Auditor.
- Qualified Quality Assurance certification.
- Health & Safety Qualifications and certification for Fire Risk assessments and health and safety audits and risk assessments on site.

If this looks of interest and you meet the requirements, don’t miss this opportunity

  • Assistant Quality Manager

    7 days ago

    Hertfordshire, United Kingdom M2R Education Limited Full time

    m2r Education are working with this training and development company who provide a range of public services, including employment support, skills training, independent living, prison education. All potential candidates should read through the following details of this job with care before making an application. In addition, they are recognised as being one...

  • Assistant Quality Manager

    7 days ago

    Hertfordshire, United Kingdom M2R Education Limited Full time

    m2r Education are working with this training and development company who provide a range of public services, including employment support, skills training, independent living, prison education. All potential candidates should read through the following details of this job with care before making an application. In addition, they are recognised as being one...

  • Assistant Quality Manager

    1 week ago

    Hertfordshire, United Kingdom M2R Education Limited Full time

    m2r Education are working with this training and development company who provide a range of public services, including employment support, skills training, independent living, prison education.In addition, they are recognised as being one of the Top 25 Education and Training providers to work for.As the Assistant Quality Manager at HMP The Mount, you will...

  • Quality Manager Life Sciences

    4 weeks ago

    Hertfordshire, United Kingdom Vector Recruitment Limited Full time

    Quality Manager - Life Sciences Location: South Cambridgeshire **Salary**: £50k-£70k + excellent benefits! A position has arisen for an experienced Quality Manager to join a rapidly expanding technology development company - specifically to work within the Life Science division. You will be responsible for managing the existing quality management...

  • Assistant Quality Manager

    7 days ago

    Hertfordshire, United Kingdom M2R Education Limited Full time

    m2r Education are working with this training and development company who provide a range of public services, including employment support, skills training, independent living, prison education. In addition, they are recognised as being one of the Top 25 Education and Training providers to work for. As the Assistant Quality Manager at HMP The Mount, you will...

  • Assistant Quality Manager

    7 days ago

    Hertfordshire, United Kingdom M2R Education Limited Full time

    m2r Education are working with this training and development company who provide a range of public services, including employment support, skills training, independent living, prison education. In addition, they are recognised as being one of the Top 25 Education and Training providers to work for. As the Assistant Quality Manager at HMP The Mount, you will...

  • Quality Lead

    2 weeks ago

    Hertfordshire, United Kingdom Owen Daniels Consultancy Full time

    Are you an experienced Quality professional? Do you have extensive experience within a regulated industry? I want to talk to you! I am looking for candidates who have experience leading the quality function within a regulated business to join my client in Hertfordshire.  This position will be responsible for leading the quality function on site and acting...

  • Quality Lead

    2 weeks ago

    Hertfordshire, United Kingdom Owen Daniels Consultancy Full time

    Are you an experienced Quality professional? Do you have extensive experience within a regulated industry? I want to talk to you! I am looking for candidates who have experience leading the quality function within a regulated business to join my client in Hertfordshire.  This position will be responsible for leading the quality function on site and acting...

  • Quality Manager

    8 hours ago

    Hemel Hempstead, Hertfordshire, United Kingdom Martin Brower Full time

    This job is brought to you by Jobs/Redefined, the UK's leading over-50s age inclusive jobs board. 1 x Quality Manager - Full Time, Permanent Location: Hemel Hempstead Shift Pattern: Monday to Friday, 37.5 hours per week This is an onsite role at our Hemel Hempstead DC, HP2 7EQ Job summary: Day to day management of the site Quality systems ensuring...

  • Quality Lead

    2 weeks ago

    Hertfordshire, United Kingdom Owen Daniels Consultancy Full time

    Are you an experienced Quality professional? Do you have extensive experience within a regulated industry? I want to talk to you! I am looking for candidates who have experience leading the quality function within a regulated business to join my client in Hertfordshire.  This position will be responsible for leading the quality function on site and acting...

  • Quality Systems Associate

    1 month ago

    Hertfordshire, United Kingdom Blackfield Associates Full time

    A global pharmaceutical organisation are currently recruiting for a Quality Systems Associate to join their facility based in the Hertfordshire area on an initial 12 month FTC basis, due to an increase in workload. Reporting to the Senior Manager, Regional Quality Systems, you will be responsible for reviewing and maintaining quality policies and Regional...

  • Quality Manager

    4 weeks ago

    Watford, Hertfordshire, United Kingdom Radar Recruitment Full time

    We are currently seeking an ambitious, dynamic and driven Quality Manager with extensive pharmaceutical experience to join a rapidly growing generics business based in Hertfordshire. About the business and the role: Our client are a small pharmaceutical business, with a growing portfolio of generic products, supplying into the UK market. The Quality...

  • Quality Manager

    4 weeks ago

    Watford, Hertfordshire, United Kingdom Radar Recruitment Full time

    We are currently seeking an ambitious, dynamic and driven Quality Manager with extensive pharmaceutical experience to join a rapidly growing generics business based in Hertfordshire. About the business and the role: Our client are a small pharmaceutical business, with a growing portfolio of generic products, supplying into the UK market. The Quality...

  • Quality Manager

    2 weeks ago

    Watford, Hertfordshire, United Kingdom Radar Recruitment Full time

    Job Description We are currently seeking an ambitious, dynamic and driven Quality Manager with extensive pharmaceutical experience to join a rapidly growing generics business based in Hertfordshire. About the business and the role: Our client are a small pharmaceutical business, with a growing portfolio of generic products, supplying into the UK market. ...

  • Manager/Quality Manager

    8 hours ago

    Hemel Hempstead, Hertfordshire, United Kingdom Martin Brower Full time

    1 x Quality Manager - Full Time, Permanent Shift Pattern: Monday to Friday, 37.Day to day management of the site Quality systems ensuring that the DC receives the necessary support to enable the smooth running of the operation. To support Martin Brower Strategy and its implementation in the area of Quality. To be the Distribution Centre (DC) representative...

  • Assistant Quality Manager

    1 week ago

    Hemel Hempstead, Hertfordshire, United Kingdom M2R Education Limited Full time

    m2r Education are working with this training and development company who provide a range of public services, including employment support, skills training, independent living, prison education. In addition, they are recognised as being one of the Top 25 Education and Training providers to work for. As the Assistant Quality Manager at HMP The Mount, you will...

  • Assistant Quality Manager

    1 week ago

    Hemel Hempstead, Hertfordshire, United Kingdom M2R Education Limited Full time

    m2r Education are working with this training and development company who provide a range of public services, including employment support, skills training, independent living, prison education. In addition, they are recognised as being one of the Top 25 Education and Training providers to work for. As the Assistant Quality Manager at HMP The Mount, you will...

  • Health & Safety Quality Manager (Permanent)

    5 days ago

    East Hertfordshire, Hertfordshire, United Kingdom Saffron Vantage Ltd Full time

    Job Title: Health, Safety & Quality Manager Location: Head Office/Site Report to: Operations Director Role summary: The HSQ Manager is responsible for ensuring the safe running and quality of ALL live projects. The role is required to carry out regular site inspections and integrate with the site team in order to identify current and upcoming risks to...

  • Health & Safety Quality Manager (Permanent)

    1 month ago

    East Hertfordshire, Hertfordshire, United Kingdom Saffron Vantage Ltd Full time

    Job Title: Health, Safety & Quality Manager Location: Head Office/Site Report to: Operations Director Role summary: The HSQ Manager is responsible for ensuring the safe running and quality of ALL live projects. The role is required to carry out regular site inspections and integrate with the site team in order to identify current and upcoming risks to...

  • Performance Management and Quality Assurance Coordinator

    4 weeks ago

    Watford, Hertfordshire, United Kingdom Radar Recruitment Full time

    We are currently seeking an ambitious, dynamic and driven Quality Manager with extensive pharmaceutical experience to join a rapidly growing generics business based in Hertfordshire. Our client are a small pharmaceutical business, with a growing portfolio of generic products, supplying into the UK market. The Quality Manager role is a key hire for the...