Role: Quality Engineer - Medical Device / Pharma / Life Sciences - Permanent
Location: North West
Salary: Competitive + Bonus + Benefits
Russell Taylor Group has a fantastic opportunity for an experienced Quality Engineer to join a Global Manufacturing Medical Device Company based within the North West of the UK. If you have worked within the Medical Device / Pharmaceutical / Life Sciences Industry we would love to hear from you. You will be responsible for the continual improvement of processes and records related to validation, to drive improvements within the QA department.
- Main point of contact for validation plans, protocols and reports; and responsible for developing, reviewing validation plans, strategies, protocols and reports.
- Evaluates and establishes evaluates adequacy of validation methods for new or modified processes, equipment or facility changes.
- Develops and reviews risk assessments and risk strategies. Able to effectively use risk assessment tools like FMEAs and FTAs.
- Manages, reviews, and approves Change Control packages for all types of changes (e.g. documents, equipment, facilities, instrumentation, process, cleaning).
- Develops quality systems, performs gap analysis, makes recommendations and initiates plans to improve existing systems.
- Identify new, or changes to existing, supplier quality systems to improve effectively and efficiency, where required.
- Conduct quality assessments (Audit) of current suppliers, report findings and recommendation where required.
- Performs internal and external audits if required.
- Perform other related duties as assigned.
- BSc or similar related degree within a scientific discipline, Engineering or have over 6 years industry knowledge within either, Medical Device / Pharmaceutical / Life Sciences.
- Familiar with ISO quality requirements such as ISO 13485 / ISO 17025 and Quality System regulations QMS Systems.
- Must have advanced knowledge of QA, Manufacturing, Validation, Change Control, and Design Control processes.
- Competent in validations, data evaluation methods, analytical methods, process, validation methods, DOE, ANOVA, SPC, Engineering drawings.
- Must demonstrate initiative, balanced assertiveness working as a team player
- Solid oral and written communication skills.
- Ability to manage multiple projects.