Senior Quality Assurance Specialist
Maintain and enhance quality systems within a regulated environment to ensure compliance with industry standards.
* Develop and revise Standard Operating Procedures (SOPs) and quality documentation.
* Conduct internal audits to ISO 13485 standards and identify areas for improvement.
Bachelor's degree in Science, Engineering, or a related field is required. Minimum of three years of experience as a Quality Engineer in an ISO 13485 regulated environment, along with certification as an Internal Auditor, is highly valued.
Responsibilities:
Quality Systems Maintenance and Enhancement
Lead the development and implementation of quality management systems aligned with regulatory requirements.
* Implement corrective actions based on audit findings and trend analysis.
* Coordinate validation activities for new products and processes.
Documentation and Record-Keeping
Develop, review, and maintain SOPs, quality documentation, and records to ensure compliance with regulatory requirements.
* Manage document control processes, including approval, revision, and destruction of documents.
* Ensure accurate and timely documentation of quality events and training activities.
Audit and Compliance
Conduct internal audits to ensure adherence to ISO 13485 standards and regulatory requirements.
* Identify and address audit findings through effective corrective action plans.
* Collaborate with cross-functional teams to implement audit recommendations.
Continuous Improvement
Promote a culture of continuous improvement by analyzing data and implementing process improvements.
* Develop and track key performance indicators (KPIs) to measure quality performance.
* Identify and prioritize opportunities for process improvements.
Benefits:
* Opportunities for professional growth and development.
* Collaborative work environment.
* Competitive compensation package.
This role offers a unique opportunity to join a dynamic team dedicated to delivering high-quality products while ensuring compliance with regulatory requirements. If you are passionate about quality assurance and want to take your career to the next level, we encourage you to apply for this exciting opportunity.