The Quality Engineer develops and implements quality plans, programs and procedures.
Quality Engineer- Medical devices- South East
The Quality Engineer develops and implements quality plans, programs and procedures using quality control statistics, lean manufacturing concepts and analyses. Ensures that performance and product quality conform to established company, customer and regulatory requirements. Reviews, analyses and reports on quality discrepancies related to assembly and process. Investigates problems and recommends disposition, modification and corrective action for recurring or non-recurring discrepancies.
- Lead & co-ordinate the day-to-day activities of the Quality Department
- Provide technical support during the NPI process in ensuring that from a Healthcare/Medical device perspective that all FDA, QSR, & MDD standards are achieved and maintained in respect to device classifications.
- Fully competent in the application of quality engineering tools and techniques with key emphasis on validation protocols (DQ, IQ, OQ, & PQ), cGMP, PFMEA's & support the generation of DMF's where appropriate
- Individual shall be a leader in this field and support the necessary validation protocols, & amendments of the quality management system in ensuring compliance with the latest FDA directives/requirements within the Medical Device Sector.
- Evaluation and contribution of regulatory information to applicable documents.
- Individual shall support the external & internal Quality Management System auditing function (auditor trained)
- Individual shall have exposure & involvement in supporting the CAPA system.
- Close liaison and networking with other departments, to provide and drive quality inputs and initiatives into the overall operational activities of the company.
- Support the implementation of Company Policies and GMP.
- Support External/Internal audit program.
- Supports all company safety and quality programs and initiatives
- Ensure ongoing compliance with GMP in all practices, recording of events and processes.
- Ensure compliance with all learnings from all GMP training events.
- Other responsibilities may be assigned from time to time as needed, based on the evolution of the company and the requirements of the department/position.
Education and experience:
- Degree in Engineering / Science (Mechanical / Electronics / Chemistry) discipline.
- 5 years' experience in a Quality Engineering role with experience in manufacturing within GMP environment.
- Experience in sterilisation, automation, equipment/software validation desirable.
- Fully competent in Quality Management Standards.
- Excellent Leadership skills, ability to motivate team members within the organisation. (Energetic & enthusiastic individual).
- Excellent organisation, communication, computer & presentation skills.
- Excellent initiative, decision making and be able to work in a core team environment.
- Solution driven with emphasis on performance and results.
Morgan McKinley is acting as an Employment Agency in relation to this vacancy.
Please note that any references to salary or pay rates in this advertisement and in the salary refinement section are indicative only and should only be used as a guide.