Quality Investigation Engineer

3 weeks ago

Edinburgh, United Kingdom Cpl Life Sciences Full time

Stop the press Calling all Quality professionals who enjoy working across the full product lifecycle - from product concept through to manufacturing support. Within this Quality Investigation Engineer role you will have the opportunity to work with thequality systems, continuous improvement, verification/validation activities etc.

**Role Responsibilities**:

- Monitor and report on all activities, processes, and procedures of the quality management system.
- Assist in the logging, investigation, analysis and documentation of complaints, non-conforming product and CAPA.
- Support Supplier approvals and re-assessments in accordance with planned requirements.
- Create, maintain and evaluate product/process trends, design and participating in process and product changes to improve product quality.
- Contribute to the development of company policies, processes, and procedures.
- Inspection and release of materials, processes, and products (on-site or remote), ensuring compliance with stated requirements.
- Assist in risk assessment activities for relevant processes/products (i.e. dFMEA, pFMEA) ensuring compliance with ISO14971.
- Assist in the validation planning and preparation of processes/products which require validation.
- Support document control activities.
- Support QMS training activities.

Experience Required:

- Strong written and verbal communication skills.
- Strong root cause/corrective action skills.
- Strong analytical, problem solving skills.
- Experience of working to quality & regulatory standards including ISO13485.
- Comfortable with dealing with contractors, clients & the regulatory authorities.
- Familiarity with ERP, electronic document control systems, CAPA and training software packages.
- Ability to develop good working relationships with colleagues at all levels of the organisation and perform both independently and as part of a team.

This role will require infrequent travel to local CEM partner so a driving license is required.

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