Job Title: Quality Assurance Specialist
We are seeking a highly skilled Quality Assurance Specialist to support cutting-edge projects and drive product excellence.
About the Role:
* Develop and execute validation protocols and reports for new product introductions and revalidations.
* Spearhead continuous improvement initiatives through Lean Six Sigma methodologies.
* Maintain compliance with regulatory standards, including ISO 13485 and ISO 14001.
* Lead cross-functional teams, collaborating with vendors on key projects.
* Conduct risk assessments and root cause analyses, implementing corrective actions via change management.
* Support GMP and regulatory audits, ensuring seamless execution.
* Deliver training and mentor colleagues to enhance validation knowledge across the business.
* Analyze data to inform strategic decision-making and process improvements.
Requirements:
* Bachelor's degree in Engineering, Polymer Science, or related field.
* Minimum 2 years of experience as a Quality Assurance Specialist in injection moulding or medical device manufacturing.
* Strong background in statistical analysis (Minitab), SPC, and validation methodologies.
* Excellent communication, interpersonal, and influencing skills.
* Proven problem-solving abilities (FMEA, Fishbone diagrams, 5 Whys, etc.).
Why Work with Us?
Join a dynamic team driving innovation and process excellence. Work in a regulated environment with opportunities to grow your expertise. Enjoy flexible engagement options, tailored to suit your career goals.