|Location: Crawley||Salary: £40000 - £45000 per annum|
|Sector: Medical Devices||Specialism:|
|Type: Permanent||Contact: Matt Henocq|
Quality Assurance Engineer
Must have experience of the standard IEC 62304 or a similar software lifecycle standard
Responsible for supporting process owners in defining and implementing processes and system changes analysing process improvements to drive efficiencies. Support the local quality management system and processes. Is an advocate of Quality and promotes the group's vision and mission while supporting the goals of the overall business. They work closely with functional teams in areas such as Engineering, Order fulfilment, Regulatory Affairs, Sales & Marketing, and Manufacturing among others.
- Work on projects / compliance activities to completion.
- Prepare monthly metrics for their area of expertise / responsibility.
- Analyse process data and trends and drives optimization / improvement.
- Represent QA organization in specific processes (e.g. CAPA, Order fulfilment, Manufacturing, etc.)
- Support others in the QA organization and other functional organizations on technical aspects in order to drive results.
- Participate in external audits before regulatory authorities.
- Participate in the execution of the internal audit plan.
Relevant Knowledge, skills and competencies -
- Bachelor's degree in Engineering or equivalent or a related field or a formal engineering apprenticeship with demonstrated experience in a similar role
- Training and experience in relevant medical device regulatory requirements and standards (e.g. ISO, IEC, MDD, QSR, CMDR.)
- Ideally have experience of IEC 62304
- Proven experience in relevant areas of Quality, Regulatory or Engineering, preferably within a medical device environment is desirable.
- Strong written and verbal communication skills and ability to collaborate effectively.
- Objective driven and customer focused. Capable of producing results working unsupervised under own initiative.
- Professional integrity. Able to translate regulations into meaningful business requirements.
- Possess a structured approach to problem solving with an appreciation of quality tools & techniques.
- Must be an effective team player with the ability to mentor, lead and problem solve to provide solutions to the business.
- Confident and open personality who is able to communicate effectively, both written and orally with people at all levels.
- Ability to work efficiently under tight timelines.
- Proven fluency in English and other applicable languages relevant to their specific geographies.
- Quality professional certifications preferred (e.g. CQI, CQMoE, CQA, CQE.)
- Experience in quality improvement tools and techniques is a plus (e.g. Lean, Six Sigma, DOE, Statistical Methods, etc.)
- Travel may be required.
Services advertised by Gold Group are those of an Agency and/or an Employment Business.