Manager, Quality Compliance

Manager, Quality Compliance, Irvine, CA

Responsibilities

Provide compliance leadership in the specific areas of, Analysis of Data, Post-Market Surveillance, Quality Systems Maintenance including changes and improvement, and will ensure ongoing compliance with all applicable regulations and standards through continuous evaluation of these systems and processes. This position is responsible for the ongoing effectiveness of these systems. This position develops and coordinates plans to identify, address and mitigate potential risks to compliance in various processes implemented to support the Company's activities. This position is expected to develop and mentor the quality compliance team, ensuring their competence, focus and productivity in relation to their specific job functions. This position will interface with individuals at all levels of the organization including other Masimo's facilities.

• Maintain, support and ensure effective implementation of the following quality systems:
  
  
  
  • Quality and Compliance Project Management
  • Analysis of Data
  • Quality Compliance Council
  • Post-Market Surveillance
  
  
• 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 21 CFR Part
• 820(QSR), EN ISO 13485, SOR 98/282 CMDR (Canada), MHLW/PMDA (Japan), RDC ANVISA #16 (Brazil), Therapeutics Goods (Medical Devices) Regulations 2002 (Australia), and EU
• MDR and MDD (European) requirements;
• Project Management: Lead specific projects focused on improvements in the following areas:
  
  
  
  • Quality and Compliance Project Management
  • Analysis of Data
  • Quality Compliance Council
  • Post-Market Surveillance
  • General improvements related to metrics reviews and the establishment of appropriate metrics.
  
  
• Responsible for preparing, maintaining, and updating procedures related to the quality management system;
• Support and ensure proper follow up to external audits (e.g., FDA Inspections, Notified Body Audits and Customer Audits);
• Support and ensure proper follow up to additional information requested by notified bodies;
• Coordination and monitoring of quality system metrics for all Masimo facilities:
  
  
  
  • 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.
  
  
• Administrative activities related to the management of the quality compliance team.
• 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.
  • Handle all department employee relations issues.
  
  
• Other projects as assigned by the Sr. VP, WW Quality and Compliance.

Qualifications

THIS POSITION REQUIRES A BACHELOR'S DEGREE (OR FOREIGN EQUIVALENT) IN ENGINEERING (MECHANICAL, ELECTRICAL, BIOMEDICAL, CHEMICAL), QUALITY ASSURANCE OR IN A CLOSELY RELATED FIELD, PLUS 3 YEARS OF WORK EXPERIENCE IN QUALITY ASSURANCE/ COMPLIANCE IN A MEDICAL DEVICE ENVIRONMENT.

IN THE ALTERNATIVE, THE EMPLOYER WILL ACCEPT A MASTER'S DEGREE (OR FOREIGN EQUIVALENT) IN ENGINEERING (MECHANICAL, ELECTRICAL, BIOMEDICAL, CHEMICAL), QUALITY ASSURANCE OR IN A CLOSELY RELATED FIELD PLUS 1 YEAR OF WORK EXPERIENCE IN QUALITY ASSURANCE/ COMPLIANCE IN A MEDICAL DEVICE ENVIRONMENT.

Special Requirements

1. Experienced in implementing QMS requirements per ISO 13485, FDA 21CFR Part 820 (QSR), SOR 98/282 CMDR (Canada), MHLW/PMDA (Japan), RDC ANVISA No.16 (Brazil) and Therapeutics Goods (Medical Devices) Regulations 2002 (Australia) and EU MDR (European Union)
2. Strong analytical and statistical skills to assess post-market, interpret trends, generate presentations and reports (PMSR/PSUR), and collaborate with Regulatory, Clinical, Engineering & Manufacturing for initiating corrective actions, as identified
3. Technical knowledge of metrics related to Post-Market Surveillance, Operations and Quality Management System, required for participation in review meetings
4. Proven experience to support notified body/regulatory authority activities including responding to additional information requests and participating in audits (leading backroom /interviewing with auditors in front room as SME)
5. Experienced in leading multiple projects involving collaboration with Regulatory, Clinical, Engineering and Manufacturing
6. Experienced in training employees in Post-Market Surveillance and Data Analysis
7. Strong proficiency in using Agile PLM, MS Project and MS Excel

Must possess expertise/ knowledge sufficient to adequately perform the duties of the job being offered. Expertise/ knowledge may be gained through employment experience or education.

Such expertise/ knowledge cannot be "quantified" by "time."

Travel: 25% worldwide travel

Salary: $132,288 - $149,000 per year.

Masimo Corporation is an equal opportunity employer.

How to apply: Qualified applicants please send resume to: Delora Sandoval: dsandoval@masimo.com. Must reference JOB CODE#: CS-25 when applying.

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