Director, Central Quality Audit

This is a fully remote position, open to applicants in United States.

📋 Description

• Overseeing, ensuring, and enhancing capabilities to meet external standards and regulations.

• Analyzes both internal and external business challenges and suggests best practices to enhance products, processes, or services.

• Implements GEHC's Central Quality & Regulatory Audit program.

• Manages scheduling, preparation, execution, reporting, and follow-up activities related to Central Quality & Regulatory Internal Audits.

• Identifies and communicates high-risk issues.

• Reports compliance concerns and proposed improvements to business leadership.

• Ensures that the audit strategy aligns with current industry practices and regulatory expectations.

• Assists with GEHC Health / Competent Authority audits.

• Prepares, manages back-room activities, tracks Lessons Learned, and drives follow-up actions.

• Supports GEHC Quality Management System by defining, tracking, and maintaining metrics to foster early awareness and visibility of Quality & Regulatory issues.

• Regularly provides advice to management in Central Quality.

• Communicates complex concepts and influences others' opinions on various topics.

⛳️ Requirements

• Active certification as a Qualified Lead Auditor.

• Master’s Degree with at least 5 years of experience in the medical device industry; or a Bachelor's Degree with a minimum of 10 years in the same field; or a High School Diploma with at least 15 years of progressive responsibility in the medical device industry will also be considered.

• Minimum of 5 years of experience directly managing Global programs to resolve quality compliance issues.

• Familiarity with Medical Device QMS requirements and regulatory standards including but not limited to FDA CFR 21 820 and ISO 13485.

• Previous experience with notified bodies or health authorities is advantageous.

• ASQ Certification (CQE, CQA, etc.) and/or Lean Certification (green belt, black belt) is a plus.

• Knowledge of design controls, design verification, and validation activities.

• Experience with production and process controls.

• Understanding of Class III US FDA PMA Device requirements.

• Proficient in CAPA, complaints, and risk management.

• Knowledge of product quality improvement using methodologies such as Six Sigma and DFR.

• Proven ability to analyze and resolve issues effectively.

• Excellent conflict-resolution skills.

• Ability to engage with top organizational leadership and both internal and external customers in a professional manner.

• Strong oral and written communication skills in English.

• Integrity: Commitment to high ethical, moral, and personal values in decision-making, communication, actions, and interactions with others.

🏝️ Benefits

• Medical coverage.

• Dental insurance.

• Vision benefits.

• Paid time off.

• 401(k) plan with opportunities for employee and company contributions.

• Life insurance.

• Disability insurance.

• Accident insurance.

• Tuition reimbursement.