Lead Auditor

Percussionaire Corporation, a world leader in medical ventilation devices is seeking a Lead Auditor for our Quality Assurance Department.

The Auditor works under the direction of the Regulatory and Quality departments to ensure the compliance and completion of assigned activities and to provide strategic input and compliance throughout the organization. The Auditor is responsible for conducting internal and external audits to ensure compliance to all standards are maintained; including, but not limited to, the organization’s adherence to ISO and FDA QSRs. This employee will provide support for the Regulatory department. This employee will participate in the supplier assessment team (SAT). The auditor will be required to perform both desktop and onsite audits for suppliers, distributors, and service centers.

Essential Functions of the Position:

  • Be current, and maintain certifications to support, in the US FDA regulations, relevant International Standards such as ISO 13485, MDD, and other International Regulations as applicable to the market and the devices, to support the continued compliance of the company.
  • Responsible for keeping current and knowledgeable of the Company’s quality policy and applicable quality objectives; provides support to achieve objectives.
  • Responsible for conducting internal audits.
  • Support the Materials Manager in the vendor selection, qualification, approval and monitoring process.
    • Supplier Assessment Team (SAT) member working cross-functionally with other departments to comply with the supplier evaluation process.
    • Performs audits of suppliers, service centers and distributors, as needed.
    • Create supplier performance metrics and report on performance to both suppliers and Percussionaire management.
  • Learn products and processes to appropriately support the customers and business.
  • Knowledge of Quality Management System (QMS).
  • Utilize IT tools for accurate, efficient and organized execution of duties as recorded in the QMS.
  • Working knowledge of standards and regulations as outlined in the QMS documentation and structure.
  • Understanding that device defects may occur from improper performance of specific job function.
  • Professional written and oral communications.
  • Ethics aligned with the company’s mission.
  • Utilization of IT tools provided to ensure work is organized to prevent errors and omissions.
  • Adherence to the company policies and employee handbook.
  • Ability to communicate at all levels within the organization.
  • Abide by all safety and security rules set forth by the company and regulatory agencies.
  • Performs all other duties and responsibilities assigned by the Quality Assurance Manager or its designated representative.

 

Qualifications:

Qualifications & Experience

  • 10+ years in medical device or similar industry with a minimum of 5+ years in Regulatory Affairs or Quality Assurance.
  • ISO Competency Based Lead Auditor certification.
  • Employee required to pass Lead Auditor ISO 13485-2016 Certification course.
  • Strong knowledge of FDA QSRs, ISO 134852016 related to Supplier Quality.
  • Excellent organizational skills with high level of detail orientation.
  • Ability to work well under pressure, to handle multiple tasks, and to meet aggressive deadlines.
  • Experience reading and understanding regulations, standards, drawings and procedures.
  • Excellent verbal and written communication skills.
  • Proficient computer skills with documentation related databases and Microsoft Office (Word and Excel).
  • Experience with ERP system helpful.
  • Excellent presentation skills required.
  • Clear report writing skills.
  • Ability to travel (domestic & international) up to 50% of the time.

 

Education

  • BS or higher degree, preferably in science or engineering.
  • Audit Certification

 

Competencies

  • Ability to prioritize tasks and work with little direct supervision.
  • Ability to identify problems, recommend solutions and implement corrections.
  • Ability to effectively communicate issues to peers and supervisors.
  • Ability to collaborate and coordinate effectively with various functional areas. Cross-functional team experience required.
  • Strong attention to detail, organizational, record keeping.
  • Strong communication skills with emphasis on good writing, grammar, editing, and proofreading skills.
  • Excellent interpersonal skills, to interact with all levels of personnel.
  • Self disciplined and able to meet strict deadlines.
  • Personal accountability.
  • Confidentiality.
  • Comfortable speaking to groups.
  • Able to obtain and maintain a Driver’s License and Auto Insurance.
  • Able to travel internationally, (Passport Required).

 

Special Work Conditions
This position requires 5 or more hours per day sitting and talking/listening, 0-2 hours per day standing, walking, reaching and bending. Lifting to 25 lbs. 0-2 hours per day. Moderate office noise. Daily use of a computer is required. Overnight travel is required of this position. Employee must be able to stay overnight extended periods of time. Employee must be able to operate a motor vehicle and maintain a valid Driver’s license and auto insurance. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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We encourage all qualified candidates to apply and join the Percussionaire team.

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