Job Summary
We are seeking a highly skilled Senior Quality Assurance Engineer to join our team as a Validation Expert. As a key member of our quality assurance team, you will be responsible for ensuring the highest standard of quality in our processes and systems.
Main Responsibilities:
* Develop and implement quality management systems to ensure compliance with regulatory requirements.
* Conduct internal audits to identify areas for improvement and implement corrective actions.
* Participate in customer and regulatory audits to demonstrate our commitment to quality.
* Investigate and close validation deviations, non-conformances, and CAPAs in a timely manner.
* Collaborate with cross-functional teams to develop and implement equipment validation and statistical analysis plans.
Requirements:
To succeed in this role, you will need:
* A Bachelor's Degree in Science, Engineering, or a related field.
* At least 3 years' experience working at quality engineer level in an ISO 13485 regulated environment.
* Internal Auditor qualification to ISO 13485.
* Experience with equipment validation and statistical analysis.
What We Offer:
We offer a competitive salary and benefits package, opportunities for professional growth and development, and a dynamic work environment that values teamwork and collaboration.