Quality System Internal Auditor

Position Location US-CA-Rancho Santa Margarita

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Applied Medical, a progressive medical device developer, manufacturer and distributor, invites exceptional individuals to pursue careers in our innovative organization. If you would like to be a part of one of the fastest growing and most innovative companies in the medical device field, then Applied Medical is the place for you.  Applied’s team members enjoy an environment that allows opportunity for growth and choice in individual career paths as team members develop their skills, training and business knowledge. Our common goal of improving healthcare through meeting the needs of clinicians and patients is achieved through the dynamics of our team and its universal dedication to improved patient outcomes. 

Position Description

As an Internal Auditor for Regulatory Affairs, you will be responsible for working within the framework of a team and performing the following activities:

 

  • Maintain and conduct the internal audit process
  • Generate the audit schedule, conduct audits, analyze audit results and present findings
  • Review and monitor documentation, as assigned, to ensure compliance with relevant standards, regulations and guidance documents
  • Coordinate, liaise and participate with internal teams to provide guidance on manufacturing processes or quality systems compliance
  • Learn and understand relevant domestic and international standards and regulations in order to monitor and ensure conformance
  • Analyze all elements of the Quality System and judge their degree of adherence to the criteria for management and control processes
  • Collect and analyze data to evaluate department goals and objectives for the internal audit process
  • Perform verification and effectiveness check of the action items implemented by the process owner
  • Maintain the Internal Audit database
  • Participate in supplier audits as part of critical supplier selection and evaluation
  • Interpret recommendation/observation findings from audit results to ensure that corrective actions are appropriate and effective
  • Present and distribute internal audit reports including action items from internal audit results
  • Perform additional duties and responsibilities as required by leadership
  • Work within a team environment, strive to meet or exceed customer expectations, and commit to continuous improvements in quality

 

Position Requirements

This position requires the following skills and attributes:

 

  • Ability to work independently and as part of a team
  • Analytical, meticulous and detail oriented
  • Assertive and not afraid to ask questions
  • Effective oral and written communication skills
  • Friendly, good attitude and customer service oriented
  • Strong multi-tasking, organization and prioritization skills
  • Ability to interpret existing and emerging regulations, standards or guidance documents including potential impact on regulatory and quality functions
  • Ability to analyze using statistical techniques when applicable and present data regarding QMS (Quality Management Systems)
  • Flexibility to travel, as required
  • Bachelor’s degree or equivalent years of experience in Quality Assurance or a regulated manufacturing environment
  • Training in Quality Systems including relevant regulations and standards
  • A minimum 2 years of experience in Quality Systems auditing

 

Preferred

  • ASQ-CQA, CBA or I RCA certification preferred

Benefits

  • Training and mentorship with ongoing learning and development courses
  • On-campus wellness activities
  • Comprehensive medical and dental coverage
  • Education reimbursement program
  • 401(k) program with employer match
  • Generous holiday and vacation accrual

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