Lead Auditor

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

📋 Description

• Perform third-party audit services for GMED North America’s designated clients.

• Evaluate quality systems in accordance with ISO standards ISO 9001:2015 and ISO 13485:2016.

• Review CE Marking certification as per relevant European Directives and Regulations.

• Evaluate quality management systems based on MDSAP requirements.

• Oversee a portfolio of clients based on geographical location, qualifications, and contract stipulations.

• Reach out to clients to schedule site visits.

• Organize assessments and arrange travel logistics.

• Execute client-site assessments.

• Prepare audit reports and manage the outcomes.

• Engage in professional growth and training to obtain necessary certifications and qualifications.

• Ensure prompt, cost-efficient service delivery and maintain customer satisfaction.

⛳️ Requirements

• Bachelor’s degree in computer and software technology, biology, chemistry, biochemistry, electrical/electronic/mechanical engineering, human physiology, medicine, physics, or biophysics.

• At least four years of full-time hands-on experience (R&D, manufacturing, testing, and/or auditing) in the medical devices field or related sectors.

• A minimum of two years in quality management, working within an organization subject to regulations and standards.

• Practical technical experience with both active and non-active devices, as well as plastics and metals.

• Familiarity with ISO 9001:2015 and ISO 13485:2016 standards.

• Understanding of CE Marking certification and relevant European Directives and Regulations.

• Knowledge of MDSAP requirements.

• Proficiency in the English language.

• Capability to create demonstrative records and reports.

• Commitment to impartiality and confidentiality.

• Ability to work independently and collaboratively within a team environment.

• Strong organizational skills and time management abilities.

• Keen attention to detail.

• Excellent oral and written communication skills.

• Strong critical reasoning and decision-making skills.

• Leadership qualities.

• Dependability and accountability.

🏝️ Benefits

• Group-sponsored health, dental, and vision insurance.

• Flexible spending accounts.

• Short-term and long-term disability coverage.

• Company-paid life insurance.

• Competitive base salary.

• Annual bonus linked to company performance.

• 401K retirement plan.

• Option for teleworking.

• Flexible working arrangements.

• Generous paid time off program.

• Paid holidays.

• Paid bereavement leave.

• Paid parental leave.

• Commuter benefits for public transportation.

• Internet stipend.

• Opportunities for growth within the organization.

• Potential to apply for and transition into different roles within the company.