Medical Device Quality Internal Auditor

IMPACT and OPPORTUNITY

Provides independent, objective assurance and advisory services, designed to add value and minimize risk for Gentherm. This will be accomplished by designing and implementing risk-based audit programs, policies, and practices that look beyond simply assessing the single element being investigated, but rather the interaction with other systems and the effectiveness on achieving planned results.

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:

• Process owner and subject matter expert for the Quality Management System Audit Processes.
• Conduct internal quality system audits and supplier quality audits.
• Create and maintain internal/supplier audits schedule and associated metrics. Manage internal audit program.
• Support CAPA, SCAR, etc. related to audits until the closure of audit findings.
• Assure Gentherm’s internal or contracted auditors are adequately trained and qualified to perform assigned audits by virtue of their training, education, and experience.
• Communicate and coordinate audit activities with other departments.
• Recommend and implement improvements to audit programs driven by new regulations, industry standards, new technologies, and internal business needs.
• Complete required documentation, files, reports, and records in a timely manner.
• Plans, organizes, and provides training related to Quality Management System auditing and regulatory compliance, as necessary.
• Assists in the revision, writing, and/or review of SOPs and work instructions to identify areas of compliance and process improvements.
• Performs other related duties and responsibilities, as assigned.

MINIMUM QUALIFICATIONS:

• Bachelor’s Degree
• 5 years in the medical device industry or related GMP environment or equivalent
• 3 years’ experience in quality system compliance audits
• ASQ Certifications for Auditing and/or Quality Management
• Medical Device Internal Audit experience
• Excellent verbal, written and presentation skills.
• Knowledge of computer programs such as Microsoft Office (Word, Excel, PowerPoint, and Outlook).

PREFERRED QUALIFICATIONS:

• Project management or Six Sigma Green Belt training

Job Type: Full-time

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Health savings account
• Life insurance
• Paid parental leave
• Paid time off
• Referral program
• Vision insurance
• Work from home

Schedule:

• Monday to Friday

Work Location: Hybrid remote in Cincinnati, OH 45241