Engineer II, CAPA

$75,000 - $113,000/Yr

Masimo - Irvine, CA

Full-time - Mid Level

Irvine, CA

Computer and Electronic Product Manufacturing

About the position

The CAPA Engineer is responsible for Corrective and Preventive action (CAPA) activities and the management of 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.

Responsibilities

• 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.
• Ensure proper documentation of CAPA records.
• 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, 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.
• 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.
• Perform other duties or special projects as assigned.

Requirements

• Advanced computer skills including: Word, Excel, PowerPoint, and management of spreadsheets and generating reports.
• Sound organizational and planning skills with solid attention to detail.
• Critical thinking and problem solving skills.
• 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.

Nice-to-haves

• 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.
• Direct experience within the medical device industry (FDA Regulated) is strongly preferred.
• 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.

Benefits

• Medical
• Dental
• Vision
• Life/AD&D
• Disability Insurance
• 401(k)
• Vacation
• Sick
• Holiday
• Paid Maternity Leave
• Flexible Spending Accounts
• Voluntary Accident
• Critical Illness
• Hospital
• Long-Term Care
• Employee Assistance Program
• Pet Insurance
• on-site Wellness Clinic
• Fitness Center
• Cafe