- Inspect, record, and release all parts with an inspection status against their current specification sheets or physical samples. Reporting quality issues or outdated/incorrect specifications to the relevant personnel.
- Inspect, record and process returned goods and materials.
- Monitor the temperature of the UK locations
- Prepare different glue and disinfectant formulations which are used in a cleanroom manufacturing environment.
- Review and recording of product rejections from production.
- Inspect product returns for viability options.
- Carry out necessary calibration for all relevant measuring equipment to conform with the quality requirements as outlined in the calibration schedule.
- Raise purchase orders for quality consumables, spares, and services.
- Manage Quarantine area and inventory. Communicate quarantined and expired stock via a monthly report.
- Reconcile all batch reports to ensure complete batches have been processed and certified sterile retaining records for the required retention period (including PSP packs).
- Prepare, review, and sign the documentation required to produce pharmaceutical packs.
- Prepare and sign certificates of conformance for Requested client manufactured products.
- Review and File including but not limited to Certificates of conformance sent by suppliers.
- Review and sign completed check sheets for clean room pressures and cleaning.
- Organise the disposal of products where necessary.
- Undertake periodic training as required to perform duties, including health and safety, environmental and regulatory requirements.
- Follow the company's documented processes related to the assigned duties and inform of deviations, impracticalities, or absence of such documented processes.
- Co-ordinate with other team members to cover and be covered during holiday absences.
- Maintain an up-to-date multi-site filing system for all superseded technical drawings adhering to the required retention periods.
- Liaise with suppliers to obtain certification to support approved suppliers list and obtain technical information on components purchased to support colleagues
- Co-ordinate and promote continuous improvement.
- Understand and apply quality assurance procedures in line with Medical Device Directive 93/42EC, Regulation (EU) 745/2017 on Medical Devices, ISO13485, ISO14001 and health and safety standards.
- Carry out Process and Internal Audits.
- Raise CAPAs, Non-Conformities, complete investigations of root causes.
- Assist the technical department with product testing when required.
- Carry out duties in line with Good Distribution Practices (GDP)and Good Manufacturing Practices (GMP) where required and to keep the company's Responsible Person(s) informed of all relevant developments.
- Qualifications required for the Job (minimum requirement)
- GCSE standard including mathematics/sciences/English language.
- Computer Literate
- Full UK Driving Licence
- Experience required to do the job (minimum requirement)
- Previous experience in a Quality environment preferred.
- Knowledge of Medical Devices
- Knowledge of Auditing preferred.
- Skills and abilities including key competencies
- Microsoft Office
- Measuring and Analysis equipment (preferred)
- Physical Effort (Pump Trucks, Box Lifting)
- Teamwork
- Communication
- Excellent interpersonal skills
- Ability to organise own work
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Description
Quality Inspector
£23k
Monday to Friday
Duties to include
Alternative Duties to Be Performed As Required
Other duties as necessary to support the operations of the Quality and Regulatory department.
95% Warehouse & Shop Floor, 5% Office. Main locations are Bromsgrove and Worcester.
