Manager, Contract Manufacturing and Process Engineering
Description of role
- Together with COO/CTO and others defines the manufacturing strategy for the company and selection of critical contract manufacturers, critical component manufacturers, critical equipment manufacturers and critical materials.
- Ensures appropriate contracts and agreements are in place.
- Together with the contract manufacturer develops the manufacturing process with focus on design for manufacturing.
- Transfers existing processes as determined to contract manufacturer.
- Together with contract manufacturer defines critical to quality parameters and sets up key process performance indicators.
- Monitors performance of key contract manufacturers.
- Supports contract manufacturers in the providing solutions to issues and process challenges.
- Works to define the appropriate process, controls, and equipment to complete all required internal reagent manufacturing requirements
- Ensures all equipment, processes and test methods are validated in accordance with appropriate quality and regulatory standards.
- Responsible for the creation of the Device Master Record in accordance with quality and regulatory requirements.
- Assists the in developing the appropriate quality system procedures, manufacturing work instructions and records in accordance with ISO13485:2016 and the FDA Quality System Regulation.
- Hires and leads high performing teams.
- Implements Lean principles.
- Ability to influence and work as a team to deliver goals
- Strong communication skill
- Organised and execution oriented.
- High accountability to deliver on commitments.
- Must have a minimum of 5 years’ experience of manufacturing In-Vitro Diagnostics or Medical Devices. Benefit from having direct experience with the manufacture of critical Regents
- 15+ years of Manufacturing experience in a regulated environment with experience in manufacturing under ISO13485:2016 and FDA Quality System Regulation
- 3+ years’ experience of implementing Lean Principles within a regulated manufacturing environment
- Educated to Degree Level in Manufacturing or Engineering Discipline.
If you are interested, then please send a covering letter and CV for the attention of Helen Armes to email@example.com