Job Summary
As a Quality Assurance Specialist, you will play a vital role in maintaining and enhancing quality systems within a regulated environment.
Key Responsibilities include:
* Maintaining and improving quality systems aligned with ISO 13485, ISO 9001, and applicable medical device regulations.
* Developing and revising SOPs and quality documentation.
* Conducting internal audits to ISO 13485 standards.
* Participating in customer and regulatory audits.
* Supporting new product development, including trials, sampling, and production runs.
* Monitoring vendor performance, issuing non-conformance reports (NCMRs), and implementing controls to protect product integrity.
* Reporting on quality performance metrics and leading change control initiatives.
* Investigating and closing validation deviations, non-conformances, and CAPAs.
Requirements:
* Bachelor's degree in Science, Engineering, or a related field.
* Minimum of 3 years experience as a Quality Engineer in an ISO 13485 regulated environment.
* Certified Internal Auditor to ISO 13485.
* Proven experience in equipment validation and statistical analysis.
* Strong interpersonal skills, attention to detail, and a proactive problem-solving mindset.
Why You Will Love This Role:
* Be part of a team that values precision, collaboration, and continuous improvement.
* Gain exposure to a wide range of quality assurance activities in a regulated industry.
* Develop your career in a supportive environment with opportunities for growth and learning.