Description
Quality Engineer/Leeds/12 Months Contract/Up To £34 Per Hour
The Quality Engineer is 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 DePuy
- 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 DePuy 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
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
The Company
Johnson & Johnson is an American multinational medical devices, pharmaceutical and consumer packaged goods manufacturer founded in 1886.
If you match these requirements, please apply in the normal way. Elevate will send you an email, please open, and action that email and your application will be visible to the hiring organisation directly.