Kimball Medical Solutions is looking for a Quality Assurance Team Leader to lead their validation group, metrology, regulatory compliance, and maintain their quality management system, ensuring adherence to ISO 13485 standards and product life cycle compliance.
Requirements
- Extensive experience in quality management systems, particularly in medical device manufacturing.
- Familiarity with FDA regulations (21 CFR Part 820) and ISO 13485 standards
- Experience in conducting internal and external audits
- Ability to analyze data and implement corrective actions
- Certifications such as Six Sigma, Certified Quality Engineer (CQE), or Certified Quality Auditor (CQA) can be beneficial.
- Ensure KEIND processes comply with regulatory standards
- Lead root cause analysis investigations and oversee the implementation of robust corrective and preventative actions
Responsibilities
- leading our validation group
- metrology
- regulatory compliance
- helping maintain our quality management system
- Ensuring adherence to ISO 13485 standards
- offering expert guidance on regulatory matters
- acting as back up to the Quality & Regulatory Manager
Other
- Bachelor’s degree or equivalent experience
- Proven track record of leading teams and managing multiple projects.
- Ability to provide guidance and mentorship to team members to foster their professional growth
- Strong verbal and written communication skills across all levels of the company
- Effective problem-solving and decision-making abilities.
