Quality Engineer

JR United Kingdom; Crawley; On-site; GBP 40,000 - 55,000; Full time

Job summary

A leading company in Crawley is seeking a Quality Engineer to support quality management systems and ensure compliance with medical device regulations. The role involves collaboration with various teams, conducting audits, and driving process improvements. Ideal candidates will have a relevant engineering degree and experience in quality assurance within the medical device sector.

Qualifications

• Experience in relevant medical device regulatory requirements and standards.
• Lead audit trained in ISO13485/9001.
• Proven experience in Quality, Regulatory or Engineering.

Responsibilities

• Support local quality management system and processes.
• Prepare monthly metrics and analyze process data.
• Participate in external audits and prepare audit reports.

Skills

Communication

Problem Solving

Team Collaboration

Customer Focus

Education

Bachelor's degree in engineering

Job description

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As a Quality Engineer, you will support the local quality management system and processes. You will act as an advocate of Quality and promotes the group's vision and mission while supporting the goals of the overall business. You will work closely with functional teams in areas such as, Supplier Quality, Manufacturing ,Order fulfilment, and Regulatory Affairs, among others.

Responsibilities

• Work on projects / compliance activities to completion.
• Prepare monthly metrics for their area of expertise / responsibility.
• Analyze process data and trends and drives optimization / improvement.
• Represent QA organization in specific processes (e.g. CAPA, Order fulfillment, Manufacturing, Deviation management etc.)
• Support others in the QA organization and other functional organizations on technical aspects to drive results.
• Participate in external audits before regulatory authorities.
• Promote and maintain adherence to company values.
• Preparation of Internal audit plans, execution of audits and preparation of audit reports as applicable.

Required skills and experience

• 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, MDR, MDSAP.)
• Lead audit trained in ISO13485/9001
• Proven experience in relevant areas of Quality, Regulatory or Engineering, preferably within a medical device environment.
• Strong written and verbal communication skills and ability to collaborate effectively as part of a team.
• 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.
  

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