Quality Engineer
- Job Type: Full-time, FTC until end of March 2025
- Location: Cardiff
- Salary: Up to 40,000
We are seeking a Quality Engineer for our client based in Cardiff to perform critical engineering activities, ensuring the development and sustainment of medical device designs and manufacturing processes are safe, efficacious, and compliant. This role is integral to delivering efficient designs and processes that result in medical devices meeting the highest standards of safety and compliance.
Day to Day of the Role:
- Execute quality planning, design control, process control, verification, and validation procedures.
- Review and approve product and process documentation across the product lifecycle.
- Apply risk management procedures to identify and mitigate product and process risks.
- Support documentation requirements and technical enquiries for legal manufacturers.
- Utilise statistical analysis to provide data-based insights during design, verification, validation, and post-launch phases.
- Employ problem-solving tools to document and resolve technical issues.
- Evaluate and audit the supplier base to ensure compliance and quality of external supply.
- Coordinate supplier corrective action requests and ensure timely resolution of quality issues.
- Engage in supplier communication and improvement activities to enhance the quality and cost-effectiveness of products and services.
- Compile and analyse supplier quality performance metrics for management review.
- Perform additional essential duties as required.
Required Skills & Qualifications:
- HND or equivalent in engineering, science, or technology discipline.
- Lead Auditor qualification in a regulated industry (ISO 9001/13485 preferred) or experience conducting audits.
- Preferably a minimum of one year in a quality-related field, ideally within a Medical Device design environment.
- Ability to interpret technical standards, drawings, and specifications, with an understanding of metrology.
- Excellent report writing, presentation, and verbal communication skills.
- Proficiency in inferential statistical techniques, sampling techniques, MSA, DoE, etc.
- Experience with risk management techniques including FMEA.
- Familiarity with formal problem-solving techniques.
Benefits:
- 25 days annual leave pro rata plus bank holidays
- 10% annual bonus
- Training and development opportunities
- Possibility of a permanent opportunity after the FTC, dependant on performance and company requirements
To apply for the Quality Engineer position, please submit your CV and cover letter detailing your relevant experience and why you are interested in this role.