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Job Details

Quality System - Engineering - Internal Auditor Job

Location
Rancho Santa Margarita, CA

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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 vacation accrual and paid holiday schedule
Job Criteria:
Start Date:
Position Type: Full-Time Permanent
Years of Experience Required:
Education Required:
Overnight Travel:
Vacation Time:

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