Quality Engineer (contract) - Leeds
|Job Title:||Quality Engineer (contract) - Leeds|
|Location:||Leeds, West Yorkshire|
|Contact Name:||Nathan Wilson|
|Job Published:||September 16, 2017 14:41|
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
- 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
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