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Quality Manager - Southern

Excellent Package + Relocation - Quality
Ref: 195 Date Posted: Wednesday 07 Nov 2018
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Quality Manager

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Excellent Salary.

Our client has over 40 years’ experience in tool making, injection moulding, thermoforming, finishing and assembly in every conceivable product category including Automotive, Electronics, Aerospace, Medical and Telecommunications.

Based in Plymouth, we are now looking to recruit an experienced Quality Manager to participate in the design and manufacturing process to ensure products meet SQCD requirements. Provides strategic direction to all quality assurance and quality systems compliance activities in support of the company’s activities. Assures those quality systems procedures, processes, practices and controls are properly developed, implemented and maintained.  Assures that all products represent the maximum quality and reliability attainable. Routinely provides guidance and leadership to engineers, inspectors and/or technicians for the duration of a project assignment. Key role in ensuring product issues are promptly investigated and adequate corrective/preventive action implemented e.g. customer complaints, out of specification components, etc. Ensures the CAPA systems are operating effectively and close out of corrective actions meets expected deadlines.

 

 

Key Result Areas

 

  • Devising and establishing a company's quality procedures, standards and specifications;
  • Reviewing customer requirements and making sure they are met;
  • Working with other departments where necessary to establish quality requirements from external suppliers;
  • Setting standards for quality as well as health and safety;
  • Making sure that manufacturing or production processes meet international and national standards;
  • Looking at ways to reduce waste and increase efficiency;
  • Defining quality procedures in conjunction with operating staff;
  • Maintaining controls and documentation procedures;
  • Monitoring performance by gathering relevant data and producing statistical reports;
  • Making suggestions for changes and improvements and how to implement them;
  • Using relevant quality tools and making sure managers and other staff understand how to improve the business;
  • Making sure the company is working as effectively as possible to keep up with competitors

 

Principal Responsibilities 

  • Provide leadership and management of all QA/RA staff
  • Resource planning in QA/RA
  • Drive regulatory compliance strategies
  • Implementation of the Manufacturing Quality Management System (QMS) to meet relevant regulatory requirements.
  • Reports on the current/ongoing status of the QMS to the MQR.
  • Manages the QMS improvement processes.
  • Oversees the Document Change Control process.

 

Other Related Duties 

  • Administer the Management Quality Review process.
  • Oversee the Internal Quality Audit programmes.
  • Coordinate external audits.
  • Effectively communicate quality related activities to the organisation.
  • Organise quality overview training for the organisation.
  • Maintain and continuously improve 6s and Health and Safety for all stakeholders.
  • Operate the business in a manner which is responsible in terms of its impact on the environment, the local community and society at large.
  • Will undertake any assignment or duty as required by business needs.

 

Qualifications and Experience

  • HND or equivalent in an appropriate scientific or relevant discipline/equivalent experience.
  • Minimum of five years within a medical device manufacturing facility.
  • Certified Lead / Principal Auditor Experience in QA or Document Management
  • A sound understanding of Quality approaches & techniques relating to the Manufacturing Business.
  • Experience in an FDA front office inspection environment.
  • Leadership and Communication skills which can be effective at all organisation levels and across national and cultural boundaries.
  • An awareness of the Medical Regulatory obligations
  • MDSAP awareness
  • Minimum of 5 years’ experience in a Quality Management Role

 

Specialists in consultancy


At Medical Engineers we have a range of technical consulting jobs in the medical engineering industry throughout the UK. Requiring a broad range of technical and management skills and most importantly the ability to communicate effectively. Consultancy roles require candidates with unique abilities. Roles vary in length of contract depending on clients’ requirements.

Our degree qualified consultants have specialist knowledge of the UK medical engineering consultancy job market. We have a successful track record in finding the best candidates for our clients who know and trust Medical Engineers to understand their business requirements.

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