Quality Engineer

IntaPeople Limited; Cardiff; On-site; GBP 30,000 - 40,000; Full time

Job summary

A pioneering medical device manufacturer in Cardiff is seeking an experienced Quality Engineer to enhance quality processes and documentation. This role involves executing quality planning, risk management, and supporting technical documentation for innovative medical devices. Candidates should hold an HND in engineering or a related field and ideally have experience in quality control within regulated environments. Excellent communication and analytical skills are essential. Join a dynamic team making a significant impact on healthcare.

Qualifications

• Preferably minimum of one year in a quality related field, beneficial if within a Medical Device design environment.
• Experience of a range of inferential statistical techniques, sampling techniques, Measurement System Analysis, Design of Experiments.
• Good understanding of metrology and measurement considerations.

Responsibilities

• Execute procedures regarding quality planning, design control, and process control.
• Review and approve product and process documentation throughout the product lifecycle.
• Ensure risk management procedures are fully applied.

Skills

Process Validation experience (IQ, OQ, PQ)

Excellent report writing and presentation skills

Ability to interpret technical standards

Experience of risk management techniques including FMEA

Exposure to common formal problem-solving techniques

Education

HND equivalent calibre in engineering, science or technology discipline

Job description

A highly innovative medical device manufacturer is actively looking for an experienced Quality Engineer to join their team. They are genuinely revolutionising certain applications within their field and the successful candidate will be working on high tech, innovative products which will have a huge impact on people’s lives.

Duties & Responsibilities

• Execute procedures regarding quality planning, design control, process control, verification, and validation to aid delivery of efficient designs and processes which provide safe, effective, and compliant medical devices.
• Review and approve product and process documentation throughout entire product lifecycle to ensure compliant, effective, and suitably robust design solutions are fully documented.
• Ensure risk management procedures are fully applied identifying product and process risks and that risk mitigations are implemented to ensure safe and compliant medical devices.
• Support legal manufacturers documentation requirements and technical enquiries to demonstrate company’s state of the art regulatory solutions for applicable markets.
• Apply statistical analysis procedures to product and process data during design, verification, validation and post launch to provide objective, data-based analysis and conclusions.
• Support the application of problem-solving tools, to achieve documented resolution of technical issues affecting the product or process.

Skills & Experience

• HND equivalent calibre in engineering, science or technology discipline
• Preferably minimum of one year in a quality related field, beneficial if within a Medical Device design environment or equivalent regulatory controlled environment
• Process Validation experience (IQ, OQ, PQ)
• Ability to interpret technical standards, technical drawings and specifications with a good understanding of metrology and other measurement considerations.
• Excellent report writing and presentation skills, good verbal communication skills.
• Experience of a range inferential statistical techniques, sampling techniques, Measurement System Analysis, Design of Experiments.
• Experience of risk management techniques including FMEA.
• Exposure to common formal problem-solving techniques.