Senior Director of Quality Systems

2 weeks ago

Irvine, California, United States Masimo Full time
Job Summary

As a Senior Director of Quality Systems, you will be responsible for providing compliance leadership in External Audits, CAPA, Complaints, Medical Device and Vigilance Reporting, Quality Systems Management. You will ensure ongoing compliance with all applicable regulations and standards through the management, continuous review, and ongoing effectiveness of these systems. You will develop and coordinate plans to identify, address, and mitigate potential risks to compliance in various processes implemented to support the Company's activities. You will develop and mentor the quality compliance team, ensuring their competence, focus, and productivity in relation to their specific job functions. You will interface with individuals at all levels of the organization, including other Masimo facilities.

Duties and 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), 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 and Preferred Qualifications and Experience
  • 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 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.

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