Certification Auditor, Senior (Medical Devices)

SGS; United States; Remote; USD 90,000 - 125,000; Full time

Job summary

An established industry player is seeking a Senior Medical Device Auditor to perform critical third-party audits for medical devices. In this remote role, you will leverage your extensive experience with ISO standards and ophthalmology devices to guide audit teams and ensure compliance with regulatory requirements. This position offers a dynamic work environment with up to 80% travel, allowing you to engage with clients and enhance your professional growth. Join a forward-thinking company that values integrity and excellence in the certification process, making a meaningful impact on the safety and quality of medical devices worldwide.

Qualifications

• 5+ years of experience auditing ISO 13485, MDSAP, MDD, and MDR standards.
• Possess valid auditor credentials for these standards.

Responsibilities

• Perform third-party audits per SGS Certification procedures.
• Oversee audit teams and decide on certification continuation.

Skills

Auditing ISO 13485

Ophthalmology medical devices

Leadership skills

Communication skills

Project management

Education

Bachelor’s degree in Engineering or Bioscience

Tools

MS Office Suite

Job description

Certification Auditor, Senior (Medical Devices)

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Company Description
We are SGS – the world's leading testing, inspection and certification company. We are recognized as the global benchmark for sustainability, quality and integrity. Our 99,600 employees operate a network of 2,600 offices and laboratories, working together to enable a better, safer and more interconnected world.

Job Description
As the Senior Medical Device Auditor, you will perform third-party audits per SGS Certification procedures and the requirements for ISO 13485, MDSAP, MDD and MDR standards. The Sr. Medical Device Auditor is responsible for making relevant decisions concerning the audit process and informing SGS SSC as required to resolve issues outside the audit process. You will collect and analyze information to provide a recommendation for certification. You have the authority for planning and conducting audits, including overseeing other team members.

Remote position can be located anywhere in the United States

• Must have experience with ophthalmology medical devices
• Perform audits for clients’ medical devices quality systems and technical information to ISO 13485 and other regulatory requirements such as MDSAP, MDD, MDR, and EU.
• Ensure duties are performed efficiently and expediently.
• Control teams of auditors during audits.
• Decide on certification continuation based on evidence collected.
• Acquire sufficient audit experience across SGS’s certification activities.
• Assist in training and lead auditors during audits and training sessions.
• Participate in witness audits by SGS or accreditation bodies.
• Maintain all audit credentials.
• Perform additional activities as directed by management.
• As a Lead assessor, oversee the entire audit team, which may range from one to fifteen members.
• Adhere to internal standards, policies, and procedures.
• Perform other duties as assigned.

Qualifications
Education and Experience

• Bachelor’s degree in Engineering, Bioscience, Biomedical, Science, or related field.
• Minimum 5 years of experience auditing ISO 13485, MDSAP, MDD, and MDR standards.
• Possess valid auditor credentials for these standards.
• Experience with ophthalmology medical devices is required.

Knowledge/Skills/Abilities

• Strong knowledge of technical applications of standards.
• Excellent communication skills in English.
• Basic mathematical and reasoning skills.
• Leadership skills to guide audit teams.
• Proactive, organized, and able to work under stress.
• Multitasking and project management skills.
• Integrity, tact, and character.

Computer Skills

• Intermediate proficiency in MS Office Suite.

Travel

• Up to 80% travel, including international trips with flights over 8 hours.
• Weekend travel may be required.

Salary

• $90,000 - $125,000 per year, depending on experience.

Physical/Sensory Demands

• Frequent standing, sitting, using hands, and talking/hearing.
• Occasional reaching, climbing, stooping, and lifting up to 30 lbs.

Work Schedule

• Monday to Friday, 8:00 a.m. to 5:00 p.m., with flexibility.
• Travel and extended hours may be necessary.

Additional Information

SGS is an Equal Opportunity Employer. We value diversity and inclusion. For applicants with disabilities, assistance is available upon request. All information is kept confidential according to EEO guidelines. This description is not exhaustive and may be amended as needed.