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Quality Engineering Manager

Quality
Ref: 79 Date Posted: Friday 06 Oct 2017
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Quality Engineering Manager - Medical Devices, South UK

Excellent salary + Benefits package

Our clients Manufacturing Business Centre plays a key role in the development and manufacture of new, sophisticated medical and industrial products. Working with colleagues in Europe, the USA and Japan, our multi-disciplinary team of R&D engineers is fully equipped with the latest computer-aided design and modelling technologies, to enable them to develop medical workstations and fluid management products & accessories, and industrial Remote Visual Inspection devices.

Producing world class products in terms of Quality, Cost and Delivery isn't just desirable, it's essential. Therefore, in today's fast moving, ever changing world, we continue to invest in both our people and the latest equipment and processes to remain at the forefront in manufacturing technology.

Over View of Position:

Participate in the design and manufacturing process to ensure products meet SQCD requirements. Deputise for the Quality Management Systems Representative. Provides strategic direction to all quality assurance activities in support of the company’s objectives. Assures that quality assurance 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 Areas

  • Compliance with Health & Safety & Environmental procedures
  • Successful completion of mandatory training
  • Regulatory compliance with all relevant requirements, Delivery of objectives & Demonstrate improvement.
  • Improved quality and regulatory compliance of New Product Development/Introductions, supplier material, components and finished product.

 

Principal Responsibilities

  • Supervision and management of at 7 direct reports and a team of Quality Engineers, Technicians and Quality Controllers
  • Resource planning
  • Generate control plans
  • Review and approval of technical documents
  • Problem solving
  • Supply chain development
  • Project management
  • Drive regulatory compliance strategies
  • Develop and ensure quality, regulatory and management reports are accurate and delivered within agreed timelines.

 

Other responsibilities

  • Product compliance testing & reporting
  • Participate in Continuous Improvement activities
  • Will undertake any assignment or duty as required by business needs and assigned by line management

 

Role specific competencies

  • General & Operational Management Expertise
  • Departmental/Group Objective & Target Setting
  • New Product/Change Introduction (NPI & ECR/ECO)
  • Process Validation
  • Inspection (Product, Component or Goods Received)

 

Your Qualifications:

Degree, or equivalent, in an Engineering or Life-Sciences Discipline.

Five in a Quality Systems and/or Engineering role within an Electro-Mechanical or Electronics or Sterile Medical Devices Manufacturing environment.

Experience in a Medical Device facility and knowledge of FDA Quality System Regulations (21 CFR 820), EU MDD, JPAL, ISO13485 and ISO9001.

Proven track record in a supervisory 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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