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Cincinnati Sub-Zero Products, LLC, is a leading manufacturer of Patient Temperature Management Devices and a Global provider of Industrial Test Chambers proudly serving our customers for over 75 years. We are a wholly owned subsidiary of Gentherm, the global market leader and developer of innovative thermal management technologies. With our employees, we pioneer and shape markets for our customers.

Description

The Quality Analyst – Internal Auditor is responsible for managing the compliance profile by meticulously auditing and evaluating systems & procedures against company requirements and applicable local, state, federal, and international regulations.

Provides independent, objective assurance and advisory services, designed to add value and minimize risk. 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 Duties and Responsibilities

 
  • Supports CSZ’s Mission Statement, Vision Statement, and Quality Policy.
  • 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.
  • Support CAPA, SCAR, etc. related to audits until the closure of audit findings.
  • Assure  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.
  • Keep senior management informed of all critical, major, and important audit findings including trends in findings.
  • Participate on Supplier Review Board as needed.
  • Recommend and implement improvements to audit programs driven by new regulations, industry standards, new technologies, and internal business needs.
  • Maintain current knowledge of, and compliance with, the full range of related quality systems, technology, regulatory requirements, and related policies and procedures.
  • Complete required documentation, files, reports, and records in a timely manner.
  • Maintain appropriate metrics to ensure the success of auditing and compliance activities.
  • Monitor regulatory agency activities associated with the Medical Device industry and assess its impact on trends and business focus.
  • 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.
  • Assist in the preparation, analysis, and presentation of Quality indicator metrics to support Quality Review Board and Management Review meetings.
  • Supports all company initiatives as identified by management and in support of the Quality Management System (QMS) and other regulatory compliance requirements.

Description

Ensures individual performance through:

  • Ensuring personal knowledge of relevant systems and procedures is kept current.
  • Adhering to the Compliance Program, including following all regulatory and company policy requirements.
  • Maximizing efficiency through successful time management and the ability to prioritize daily activities independently.
  • Working to a consistently high standard, even when under pressure.
  • Being a highly motivated and organized individual who can work independently and interact successfully with other departments.
  • Performs other related duties and responsibilities, as assigned.

 Supervisory Responsibilities

  • May have direct employee supervision that will lead and direct the work of others.

 

Qualifications

  • Medical Device Internal Audit experience is required.
  • Thorough knowledge and understanding of medical device regulations and standards, including but not limited to US FDA Quality System Requirements (QSR), Canadian Medical Devices Regulations (CMDR), European Medical Device Directive/Regulation (MDD/MDR), ISO 13485:2016, and other applicable industry requirements is required.
  • Excellent verbal and written communication skills, including attention to detail; strong questioning and listening skills; and the ability to look beyond obvious answers in order to understand the impact on other areas is required.
  • Must have ability to make effective presentations to all levels of the organization.
  • The proven ability to prioritize, manage multiple projects, and meet deadlines in a timely manner is required.
  • Must have the ability to work in both a collaborative (team) environment as well as perform independent work as required.
  • Strong appreciation of the impact of regulatory bodies on medical device product lifecycle is required.
  • Knowledge on computer programs such as Microsoft Office (Word, Excel, PowerPoint, and Outlook).

 

Education & Experience

  • Bachelor’s Degree required.
  • 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 required.

Project management or Six Sigma Green Belt training a plus

 

Cincinnati Sub-Zero Products, LLC, is an Equal Opportunity Employer.  All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, national origin, genetic information, sexual orientation, gender identity, disability or protected veteran status.

Job Req ID:  6541


Nearest Major Market: Cincinnati

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