Quality Assurance Specialist
This is a fantastic opportunity to play a key role in maintaining and enhancing quality systems within a regulated environment. You will be at the forefront of ensuring compliance, driving continuous improvement, and supporting product development in a dynamic and collaborative setting.
Your Key Responsibilities:
* Maintain and improve quality processes aligned with ISO 13485 and ISO 9001 standards.
* Develop and revise Standard Operating Procedures (SOPs) and quality documentation.
* Conduct internal audits to ensure adherence to regulatory requirements.
* Actively participate in customer and regulatory inspections.
* Support new product launches, including trials, sampling, and production runs.
* Monitor vendor performance, issue non-conformance reports, and implement controls to protect product integrity.
* Report on quality performance metrics and lead process improvement initiatives.
* Investigate and resolve validation deviations, non-conformances, and Corrective Action Preventative Actions (CAPAs).
* Assist in the creation and execution of validation protocols, including data analysis and test scripting.
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.
What We Offer:
* 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.
About Us:
We are a dynamic company dedicated to delivering high-quality products and services. Our team is passionate about continuous improvement and excellence.