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Quality Assurance Systems Engineer for Regulatory Compliance
hace 3 semanas
About the Role:
The Quality Assurance Systems Engineer for Regulatory Compliance plays a vital part in ensuring our quality systems are implemented and improved to meet regulatory requirements. This role requires a detail-oriented individual who can analyze and report quality system metrics to ensure effectiveness.
Responsibilities:
- Support the Corrective Action Preventive Action (CAPA) and Internal Quality Audit Systems.
- Partner with the CAPA owner to investigate issues related to audit findings.
- Ensure CAPA and Audits records follow good documentation practices and procedure requirements.
- Develop and conduct training related to the CAPA and Internal Quality Audit Systems.
- Prepare, analyze, and report quality system metrics to ensure quality system effectiveness.
- Support the Change Control process.
- Support audit activities as requested.
- Conduct requested audits as scheduled.
Requirements:
- Bachelor's degree in Industrial Engineering or similar field.
- At least 1 year of related experience.
- Previous experience working in a medical industry (FDA 21CFR part 820, ISO13485) environment is preferred.
- Strong knowledge of MS Office, Visio, SharePoint, and statistical software.
- Excellent written and verbal communication skills.
- Able to prioritize and adapt quickly to changing needs.
About Us:
SmileDirectClub is a digital brand that believes everyone deserves a smile they love. We're on a mission to provide greater access to care by leveraging proprietary technology and matching licensed professionals with customers who need orthodontic treatment.
What We Offer:
- A dynamic work environment with opportunities for growth and development.
- A competitive compensation package.
- A comprehensive benefits program.
- The chance to work with a talented team of professionals who share our passion for delivering exceptional results.
