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Job Summary:
The Internal Auditor, Quality is responsible for the execution of Internal Audit activities and assisting with the administration of the Internal Audit process in accordance with Company procedures. This position will interface with individuals at all levels of the organization to conduct audits at specified intervals and report audit findings. This position will facilitate and monitor the life-cycle of audit findings until completion.
Duties & Responsibilities:
- Maintain and support Internal Audit process:
- Adhere to approved audit plans
- Prepare audit agenda including: objective, scope and criteria
- Document findings and create audit records
- Work with departments/auditees to address identified issues, provide recommendations and facilitate the corrective action process
- Communicate action items and escalate issues to management
- Ensure audit findings are addressed in a timely manner
- Verify the effectiveness of corrective actions taken as a result of the audit.
- Prepare audit reports and maintain audit files
- Quality Metric Management:
- Assist with trend analyses related to audits (e.g. types/number of observations)
- Follow up with Process Owners to ensure actions are being completed per defined requirements
- Identify and communicate opportunities to improve the quality management system
- Research applicable regulations and standards to ensure the Company’s ongoing compliance
- Other duties or special projects as assigned
Minimum & Preferred Qualifications and Experience:
Minimum Qualifications:
- Five years of experience in regulated industry.
- Expertise in FDA 21CFR Part 820(QSR), ISO 13485, SOR 98-282 CMDR; Malaysia Medical Device Authority Act 2012 (Act 738.
- Excellent communication skills and the ability to express ideas both orally and in written form.
- Well organized and accustomed to maintaining excellent records.
- Ability to work with minimal supervision.
- Advanced computer skills including: Word, Excel, PowerPoint and management of spreadsheets and generating reports.
- Apply effective time management, critical thinking, problem solving and collaborative approaches to improving internal audit program.
- Ability to analyze situations thoroughly, identify potential problems, find and implement effective solutions.
- Ability to travel ~20%/year.
Preferred Qualifications:
- Five years of direct Quality experience, preferably in a medical device manufacturing environment.
- Experience with GCP is preferred.
- Certified Lean Sigma or Internal Auditor
Education:
Bachelor’s Degree is required (preferably in a Science related discipline), or an equivalent combination of education and related experience.
Physical requirements/Work Environment
This position primarily works in an office environment. It requires frequent sitting, standing and walking. Daily use of a computer and other computing and digital devices is required. May stand for extended periods when facilitating meetings or walking in the facilities. Some local travel is necessary, so the ability to operate a motor vehicle and maintain a valid Driver’s license is required.
The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodations may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described.
Masimo is proud to be an EOE/, M/F/D/V, and we are committed to Diversity at every level
