Jobs

Supplier Quality Engineer 8430 - UK

Quality
Ref: 135 Date Posted: Friday 15 Sep 2017
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Our client embraces innovation—bringing ideas, products and services to life to advance the health and well-being of people around the world.

This is an 12 month contract in Leeds West Yorkshire. 

JOB PURPOSE:  Responsible for providing quality assurance leadership for external operations 

MAIN DUTIES & RESPONSIBILITIES:        

  • Provide Quality point of contact for Global Supply Chain with select Preferred Suppliers and EMs
  • Provide Quality Leadership in support of External Manufacturing Outsourcing programs
  • Work at select Preferred Supplier and EM locations to
  • Produce advanced quality planning documentation
  • Conduct Process Capability Studies,
  • Drive cost improvement with the use of PE tools
  • Develop and manage First Article Inspections as required at suppliers or within the business
  • Develop supplier capability in risk assessment such as PFMEA 
  • Manage training and certification of operators and inspectors to CTQs with the suppliers as required
  • Develop and implement efficient and effective inspection points and control plans at the supplier that will provide STS status
  • Actively support all defined External Manufacturing Quality Systems goals and objectives.
  • Represent Quality at commodity team Supplier Business Review Meetings
  • Conduct on-site quality and process assessments at preferred and EM suppliers both to approve new suppliers and on an on going basis
  • Promote continuous improvement and Process Excellence activities within the Global Supply Chain
  • Review and approve Validation of new/changed production processes as required
  • Design and validate Quality System processes where appropriate (CSV and Inspection Process)
  • Participates in design evaluations where appropriate
  • Resolve problems & eliminate constraints to ensure project and supply targets are met.
  • Ensure suppliers continue to met the companies Quality requirements with regard to SEP-619 compliance 
  • Generate Quality metrics on supplier performance and establish measures to monitor quality costs and cost avoidance
  • Communicate and assure appropriate implementation of Quality Process Specifications (QPS), Quality Control Test Specifications (QCTS), and Raw Material Specifications (RMS) etc.
  • Ensure effective and timely closure on all Supplier Corrective Action Requests.
  • Maintain standards of housekeeping & GMP requirements
  • Represent the Supply Process Quality Assurance function as required by management
  • Ensure that all Health, Safety and Environmental requirements are fulfilled.

 

TO ADHERE TO THE COMPANY’S PROCEDURES AS DETAILED IN THE SOP MANUAL

 

KEY COMPETENCIES REQUIRED

  • Excellent Communication Skills
  • Pro-active approach to work with hands on ability
  • Ability to interpret, communicate, and work from drawings and specifications
  • Team Player
  • Flexible
  • Influencing skills
  • High level of validation knowledge
  • Highly computer literate
  • High level of GMP knowledge
  • Excellent project management skills
  • High attention to detail
  • High work standards
  • Excellent planning and organisation skills
  • Customer focused

 

QUALIFICATIONS & EXPERIENCE

ESSENTIAL:        

  • Third level engineering qualification (Certificate Level, College Degree, or Equivalent) preferably in a mechanical or quality discipline.
  • Minimum 5 years experience in a Quality or Engineering Function within a Medical Device / Pharmaceutical Company.
  • Knowledge of applicable production processes
  • Previous experience of product transfers/start up
  • Willingness to travel
  • Strong in root cause analysis skills
  • Strong communication, teamwork, and problem solving skills
  • Demonstrated ability to lead improvement projects with suppliers

 

DESIRABLE:        

  • Process Excellence – Green/Black belt certification
  • ISO 9001 Internal/External Auditor or ASQ Certification as an Auditor.
  • Experienced in SPC, Product Validation and ISO 13485.
  • Previous People management experience
  • Project management experience.
  • Knowledge of Orthopaedic products and manufacturing processes

 

 

THIS JOB DESCRIPTION IS NOT AN EXHAUSTIVE LIST OF THE JOBHOLDERS RESPONSIBILITIES.

 

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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