Senior Staff Quality Specialist - Remote

Overview

We are seeking a highly motivated, collaborative, results-oriented and experienced Sr.Staff Quality Specialist to join our team and help us deliver innovative medical devices to patients around the world.

In Short

• Manage, report, and monitor internal audit nonconformances.
• Oversee audit records and execute relevant metrics and reports.
• Ensure compliance with regulatory and quality standards.
• Collaborate with cross-functional teams to track audit commitments.
• Identify and mitigate risks related to audits.
• Lead continuous improvement initiatives for the audit program.
• Prepare compliance reports for senior management.
• Maintain communication with stakeholders on audit findings.
• Stay updated with industry regulations and standards.
• Manage CAPA transitions and ensure timely execution.

Requirements

• Bachelor's degree in Quality Management, Regulatory Affairs, or Life Sciences.
• Minimum 11 years of experience in quality management.
• Strong knowledge of quality management principles and methodologies.
• Proficiency in CAPA software and auditing tools.
• Excellent analytical and problem-solving skills.
• Certification in Quality Management is an advantage.
• Exceptional attention to detail and data accuracy.
• Strong organizational and time management skills.
• Ability to lead and collaborate in a team environment.
• Demonstrated integrity in handling sensitive data.

Benefits

• Medical, health, and dental benefits.
• 401k plan.
• Support for learning and growth.
• Performance-based rewards and recognition.
• Flexible work-life balance.