|Location: Blackpool, Lancashire||Salary: £35.00 - £37.00 per hour|
|Sector: Medical Devices||Specialism:|
|Type: Contract||Contact: Matt Henocq|
Duties & Responsibilities:
- Process review and optimisation of specified process area/s. (Liquids and Final Pack Value Stream)
- To input into new product development, to ensure timely introduction into production and that they are operationally cost effective.
- Initiation / completion of deviations, remedial actions, CAPA's and other quality system documentation.
- Undertake pFMEA reviews for the areas.
- Adhere to the Change Control and Design Control requirements.
- Control and direct manufacturing validation effort for existing and new processes.
- Active member of multifunctional process and production improvement team.
- Application of world class manufacturing tools and techniques (Lean, ME2) within aligned process areas.
Quality and Compliance related Responsibilities:
- Ensures that all activities are carried out in compliance with all regulations and laws governing business and quality operations (FDA / GMP / BSI / ISO, etc.).
- Responsible for ensuring company compliance with all local, national, international and company regulations, policies and procedures for Health, Safety and Environmental compliance.
- Accountable for HSE compliance for their area of responsibility.
- Previous experience in Production/Manufacturing environment essential
- Knowledge of IQ, QQ, PQ
- Ability to carry out structural problem solving and Credo based decision making skills
- Knowledge of CMW ordanization and products
- Knowledge of PEx, ME2 and Lean principals
- Knowledge of pFMEAs and BS EN ISO 14971:2012
- Knowledge of Quality Management Systems
- Understanding of the CapEx process
- Technical degree (Engineering, Science, Chemical) preferred
- Min of two years experience within in a similar industry
- Ideally certified to Green Belt standard
- Minimum 2 years experience in engineering / process engineering preferably in a medical devices / pharmaceutical environment. Proven track record of installing / validating new equipment and processes in a highly regulated environment. Experience in Lean Manufacturing Initiatives to deliver business benefit. Ability to deliver projects on time and to budget. Able to demonstrate process, equipment improvements and waste reduction savings.
Services advertised by Gold Group are those of an Agency and/or an Employment Business.