Contract Opportunity - Medical Device Auditors

Location: Remote, United States; authorized travel to and auditing services in the United States, Canada, and Mexico; travel up to 80%, including automobile and airplane travel, with possible weekend travel.

Company

hirify.global provides inspection, verification, testing, and certification services through a global network of offices and laboratories.

What you will do

• Perform third-party audits of clients’ medical device quality systems and technical information against ISO 13485, MDSAP, MDD, MDR, EU, and other regulatory requirements.
• Collect and analyze sufficient audit information to recommend certification.
• Decide whether registration should be recommended or allowed to continue based on audit evidence.
• Participate in witness audits conducted by hirify.global or accreditation bodies.
• Maintain audit credentials and follow internal standards, policies, and procedures.
• Make relevant audit-process decisions and inform hirify.global about issues outside the audit process.

Requirements

• Bachelor’s degree in a related discipline such as Engineering, Bioscience, Biomedical, or Science.
• At least 4 years of experience working with medical devices under ISO 13485, MDSAP, MDD, and/or MDR-compliant quality management systems.
• At least 2 years of experience with non-active cardiovascular, vascular, and neurovascular implants; non-active, non-implantable ophthalmologic devices; and general non-active, non-implantable healthcare devices.
• Experience with sterilization technologies, primarily EtO, irradiation, and moist heat.
• ISO 9001 qualification.
• Strong knowledge of the technical application of relevant standards.
• Highest advanced level of English.
• Excellent communication, interpersonal, verbal, written, and presentation skills.
• Proactive attitude, strong organizational skills, ability to react effectively in stressful situations, make clear and well-founded conformity decisions, multitask, manage multiple projects, and deliver results on time.
• Integrity, tact, character, computer skills, and intermediate proficiency with MS Office Suite, including Word, Excel, and PowerPoint.

Nice to have

• Auditor credentials for one or more of ISO 13485, MDSAP, MDD, and MDR.
• Experience with ISO 14001, ISO 45001, and/or ISO 50001 management systems.
• GMP quality or regulatory experience in pharmaceuticals, cosmetics, dietary supplements, or related fields.
• Spanish language skills.

Culture & Benefits

• Contract engagement with a global inspection, verification, testing, and certification organization.
• Work is primarily remote with extensive client-site travel.
• Equal opportunity employment practices and reasonable accommodations are available.