Job Summary

Responsible for providing compliance leadership in External Audits, CAPA, Complaints, Medical Device and Vigilance Reporting, Quality Systems Management. Ensures ongoing compliance with all applicable regulations and standards through the management, continuous review, and ongoing effectiveness of these systems. Develops and coordinates plans to identify, address, and mitigate potential risks to compliance in various processes implemented to support the Company’s activities. Develops and mentors the quality compliance team, ensuring their competence, focus and productivity in relation to their specific job functions. Interfaces with individuals at all levels of the organization including other Masimo’s facilities.

Duties & Responsibilities

Maintain, support, and ensure effective implementation of the following quality systems: CAPA, Complaint Management, MDR and Vigilance Reporting, and Quality Systems Management. Ensure all areas of direct responsibility are compliant with the Company’s Quality Manual, which includes but is not limited to the following regulations and standards: FDA 21CFR Part 820(QSR), 21 CFR Part 803 and 806, ISO 13485, Canadian Medical Device Regulation (SOR 98-282), Japan’s Pharmaceutical and Medical Devices Act (PMDA), Brazil GMP, Therapeutic Goods Regulation (Australia), EU MDR (2017/745) and Medical Device Directive (93/42/EEC) (European) requirements. Responsible for project management activities, including leading specific projects focused on improvements in CAPA, Complaints, MDR and Vigilance Reporting,  metrics reviews and the establishment of appropriate metrics, and Management Review.  Responsible for preparing, maintaining, and updating procedures related to the quality compliance department. Serve as the Deputy Management Representative. Responsible for communicating (e.g., verbal and written) with regulatory agencies and customers. Ensure Management Representative and senior management personnel are adequately informed of the current performance of the quality system and any need for improvements. Provide Engineering and Quality with feedback from quality metric trend reviews and the output of analysis of data activities. Oversee administrative activities related to the management of the quality compliance team. Assist with coordination, hosting and ensuring proper follow up to external audits (e.g., FDA Inspections, Customer Audits, and ISO audits). Direct, plan, delegate and manage department budget and staff including hire, promote, demote, reclassify or terminate employees, write and conduct performance appraisals and disciplinary actions plans, make salary decisions (pay increases or new hire offers), create training and employee development plans, and handle department employee relations issues. Perform other duties and projects as assigned.

Minimum & Preferred Qualifications and Experience

Minimum Qualifications

10 years of experience in Quality Assurance/Compliance in a medical device environment.  At least 7 years of experience in managing direct reports at the manager level. Experienced in FDA 21CFR Part 820(QSR), 21 CFR Part 803 and 806; ISO 13485, SOR 98-282 CMDR (Canadian Medical Device Regulation), PMDA (Japanese), Resolution RDC #59 (Brazil), TGA (Australia), EU MDR and MDD (European) requirements. Excellent communication skills both verbal and written and the ability to interface effectively with personnel at all levels of the organization, with regulatory agencies and customers. Experience utilizing project management practices and methodologies. Well-organized and accustomed to maintaining excellent records. Leadership and Managerial skills. A “hands-on” individual who is capable and dedicated to getting the job done with minimal support and direction. Ability to travel ~25%/year.

Preferred Qualifications

Experienced in the management of quality and quality compliance related quality professionals. 

Education

Bachelor’s Degree in Science, Engineering, or Management required.

Compensation

The anticipated range for this position is $195,000 - $260,000.  Actual placement within the range is dependent on multiple factors, including but not limited to skills, education, and 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.

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