Join a forward-thinking Plastics/Rubber company as a Permanent Quality Engineer, specialising in Medical and Pharmaceutical sectors. In this pivotal role, you will be instrumental in maintaining and elevating the organisation’s Quality Management System across the product lifecycle. Reporting directly to the Quality Manager, your expertise will enable seamless collaboration with internal teams and external customers, ensuring compliance with stringent regulatory standards. The role offers a stimulating environment where your problem-solving skills, technical insight, and commitment to continuous improvement will be highly valued. If you are a quality professional passionate about making an impact within a regulated, innovative industry, this is an excellent opportunity to further your career.
Responsibilities
- Act as the primary Quality Assurance liaison for designated products, engaging with customers and internal teams.
- Support validation and verification activities, ensuring timely completion and leveraging outputs to define in-process inspection criteria.
- Assist in creating and maintaining product Technical Files in line with regulatory requirements.
- Maintain and continuously improve the company’s Quality Management System and internal processes.
- Lead targeted problem-solving activities such as FMEA, RCA, CAPA, and 8D during development and production phases.
- Manage Change Control activities, ensuring adherence to relevant processes and requirements.
- Participate in internal and supplier audits, supporting the implementation of effective corrective actions.
- Promote quality awareness across all levels of the organisation through coaching and training initiatives.
- Perform additional quality-related tasks as directed by the Quality Manager.
Requirements
- Qualified in an engineering or technical discipline with industry experience, particularly within regulated environments such as Medical or Pharma.
- Solid knowledge of quality systems (ISO9001, ISO13485, CFR Part 820, ISO14971) and applicable industry standards.
- Proven experience applying Quality Tools and Techniques, including FMEA, RCA, CAPA, 8D, APQP, 5 Why, MSA, and Statistical Analysis (e.g., Minitab).
- Excellent communication skills, both written and verbal, with strong organisational and time management abilities.
- Hands-on experience creating and maintaining Product Technical Files (CE/UKCA) and applying Lean Six Sigma methodologies.
- A proactive mindset with the ability to work independently and as part of a team.
Our client offers a competitive package, comprehensive benefits, and opportunities for professional growth within a highly regulated yet innovative environment. If you are ready to contribute your expertise and drive quality excellence, we encourage you to apply today. Take the next step in your career journey with us.