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CAPA Engineer II

4 weeks ago

Irvine, California, United States Masimo Full time
Job Summary

The CAPA Engineer II is responsible for managing the CAPA process and workflow in accordance with Company procedures. This position will interface with individuals at all levels of the organization to facilitate and document investigations, communicate CAPA status, and to ensure consistency and completeness in the documentation for each CAPA file.

Duties & Responsibilities

This position will facilitate the investigational process relating to the determination of root cause along with responsible departments (e.g., Engineering and/or Quality Assurance) and document corrective action plans. This individual will be responsible for ensuring proper documentation of CAPA records. This person will utilize technical writing skills to ensure proper documentation of all facets of the execution of the CAPA plan and activities required to appropriately address CAPAs.

  • Maintain and Support CAPA Process:
    • Primary initiator for CAPA records
    • Facilitate the documenting of CAPA activities and assist CAPA owners with their activities, as appropriate
    • Ensure all CAPAs are closed on time and in a timely manner
    • Proficient in using CAPA root cause investigation tools
    • Provide regular reports on the status of the CAPA system
  • Quality Metric Management:
    • Prepare CAPA metrics for routine quality reviews and Management Reviews
    • Follow up with Process Owners to ensure actions are being completed per the requirements of the CAPA plan
  • Performs other duties or special projects as assigned;

Minimum & Preferred Qualifications and Experience
  1. Advanced computer skills including: Word, Excel, PowerPoint, and management of spreadsheets and generating reports;
  2. Sound organizational and planning skills with solid attention to detail;
  3. Critical thinking and problem solving skills;
  4. Skills required:
    • Strong Statistical and Analytical Skills
    • Excellent Communication skills
    • Excellent Documentation skills
    • Project Management experience
    • Flexibility and adaptability
    • Ability to work with minimal guidance from direct supervisor
    • Ability to interface with all levels across the entire organization
  5. Additional Skills
    • Effective leadership, judgment and interpersonal skills
    • Ability to lead discussions with stakeholders
    • Proven ability to demonstrate analytical capabilities (including designing and executing DOE's, statistical analysis, analytical capabilities etc.).
    • Proven basic knowledge in application of quality engineering and risk management tools such as statistics, Six Sigma, FMEA and problem solving methodologies

Preferred Qualifications
  • Strong communication and interpersonal skills with ability to work well in a high pressure environment.
  • Direct experience within the medical device industry (FDA Regulated) is strongly preferred.
  • Proven ability to demonstrate analytical capabilities (including designing and executing DOE's, statistical analysis, analytical capabilities etc.).
  • Proven ability to demonstrate strong project management and technical writing skills.
  • Comprehensive knowledge of Quality Systems, quality records, and FDA regulations (21 CFR Part 820 and Part 803) and ISO 13485 standard
  • 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.
  • Demonstrated attention to detail, strong results orientation, positive "can do" attitude, and a sense of urgency to get things done
  • 2-4 years of experience in Quality Assurance/Quality Compliance in a regulated industry. Experience in the Medical device industry (FDA Regulated) is strongly preferred

Education BS degree, or equivalent experience is required. MS degree in engineering is preferred.
Desired Certifications CQE, CQA
Compensation : The anticipated range for this position is $75,000 - $113,000. Actual placement within the range is dependent on multiple factors, including but not limited to skills, education, and experience.

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.