Quality Engineer (contract) - Leeds

Quality Engineer (contract) - Leeds

Job Title: Quality Engineer (contract) - Leeds
Contract Type: Contract
Location: Leeds, West Yorkshire
Salary: Negotiable
Start Date: ASAP
Reference: NWQualEng_1505569290
Contact Name: Nathan Wilson
Contact Email:
Job Published: September 16, 2017 14:41

Job Description

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 company
  • 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 meet Quality requirements about 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

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

  • Third level engineering qualification (Certificate Level, College Degree, or Equivalent) preferably in a mechanical or quality discipline.
  • 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
  • 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