Production Supervisor
Polytec are looking for an experienced Production Supervisor for our Saffron Walden based client who specialise in the manufacturing of Medical Devices. The successful candidate will take on the responsibility of the day to day running of an ISO 7 clean room and be responsible for a number of Production Technicians.Responsibilities: -* Plan the daily workload and execution of unit operations within the production process under ISO 5 workstations, conducted within ISO 7 clean rooms.* Unit operations encompass incoming material inspections, device assembly and electrical testing, preparation of process mixtures and of solutions for device functionality testing.* Ensure all processes and inspections are conducted according to approved QMS (Quality Management System) documentation.* Ensure availability of approved materials and calibrated / validated equipment.* Supervise production technicians.* Implement and revise QMS procedures. * Train production staff.Candidate requirements: -Essential* Degree in Chemistry, Chemical Engineering, Materials Science or Biochemistry, (2:1 or above), or equivalent.* 5 + years industrial experience in either Medical Devices or Pharmaceuticals. * 2 + years supervisory responsibility experience.* ISO 7 clean room experience (or higher specification).* QMS experience e.g. ISO 13485, ISO 9001, 21 CFR Part 820. * Awareness of Health and Safety regulations (e.g. CoSSH).Advantageous* Experience manufacturing drug/device combination products.* Demonstrated ability to troubleshoot process and equipment issues in a time-critical environment. * IQ/OQ of equipment and PQ of processes.* Understanding (or previous experience of) process FMEA and design control.* Laboratory or process scale experience of wet chemistries involving monomers and hydrogels polymers.* Analytical chemistry laboratory experience