Job Summary

The CAPA Manager will provide Corrective and Preventive Action (CAPA) process leadership, focusing on driving improvements in product and process performance and proper identification and appropriate addressing of issues relating to nonconformances. The CAPA Manager will be responsible for the effectiveness of the Corrective and Preventive Action Process and related systems. The CAPA Manager will develop a plan to bridge improvement gaps between Masimo's CAPA vision and current state and implement an integrated CAPA process plan. The CAPA Manager will be the CAPA process owner and drive execution through CAPA Engineering. The CAPA manager will be accountable for the performance of the CAPA system and metrics and will provide direction and leadership for CAPA Owners, resulting in each site successfully supporting the effective implementation, maintenance, and improvement of the CAPA process. This individual will provide leadership with the CAPA Review Board to achieve quality goals and expectations and will develop and implement an ongoing education program for the CAPA process, and will develop and implement measures to monitor the effectiveness of the CAPA process and drive for improvement. The CAPA Manager will supervise technical staff to ensure that objectives are met.

Duties & Responsibilities

• Maintain and Support CAPA Process:
  • Responsible Manager for all CAPA-related activities.
  • Ensure the appropriate documentation of all activities related to CAPA records.
  • Ensure the CAPA system is effectively implemented, and changes are made to address opportunities to improve the system.
  • Provide guidance to supporting departments and CAPA owners on best practices relating to CAPAs.
  • Provide regular reports on the status of the CAPA system
• Project Management:
  • Lead specific projects focused on improvements in the CAPA process.
  • Develop project plans
  • Provide project direction and support to project teams
  • Monitor and report on project progress to appropriate stakeholders
• Performs other duties or special projects as assigned;

Minimum Qualifications

1. Ten or more years in the medical device or regulated industry;
2. Experience interacting with FDA, notified body auditors or other regulatory authorities;
3. Knowledge of interpretation and application of QSR, MDD, and ISO 13485 are required;
4. Strong management and collaboration skills;
5. Sound organizational and planning skills with solid attention to detail;
6. Critical thinking and problem solving skills;

Skills required

• Strong Statistical and Analytical Skills
• Excellent Communication skills
• Excellent Documentation skills
• Project Management experience
• Flexibility and adaptability
• Ability to work without guidance from a direct supervisor

Preferred Qualifications

• Strong communication and interpersonal skills with the ability to work well in a high-pressure environment.
• Minimum 7 years experience working in a high-tech manufacturing environment.
• Proven ability to demonstrate analytical capabilities (including statistical analysis, etc.).
• Proven knowledge in applying quality engineering and risk management tools such as statistics, Six Sigma, FMEA, and problem-solving methodologies.
• Proven ability to demonstrate strong project management and technical writing skills.
• Strong competency in Customer Focus, Driving for Results, Integrity and Trust, Ethics and Values, and Compassion.
• Proven ability to demonstrate, at minimum, the following competencies: Action orientation, Perseverance, Dealing with Ambiguity, Learning on the fly, and Problem Solving.

Education

A bachelor of Science degree is required; a Masters's degree is preferred and may be considered instead of minimum qualifications and experience.

Compensation: The anticipated range for this position is $145,000 to $155,000. 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.