Sr Engineer, Quality Compliance

Masimo Corporation • Irvine, CA

259d • $93,000 - $120,000

About The Position

The Senior Engineer, Compliance will be responsible for the specific area of Analysis of Data in the Quality Compliance department. This position will interface with representatives from different departments within the organization (e.g. Quality Compliance, Quality Assurance, Engineering, and Operations) to prepare metrics for routine quality reviews and management reviews. This individual will also be responsible for assisting in the development of new processes within the Quality department. This person will utilize various technical skills to support activities within the Quality department.

Requirements

• Five to ten years in regulated industry
• Advanced computer skills including: Word, Excel, PowerPoint, and management of spreadsheets and generating reports
• Effective judgment and interpersonal skills; ability to interface with all levels across the entire organization
• Sound organizational and planning skills with solid attention to detail
• Critical thinking and problem solving skills
• Strong Analytical Skills
• Excellent Communication skills
• Excellent Documentation skills
• Flexibility and adaptability
• Ability to work with minimal guidance from direct supervisor

Nice To Haves

• Strong communication and interpersonal skills with ability to work well in a high pressure environment
• Minimum 4 years' experience working in high tech manufacturing environment
• Direct experience within the medical device industry (FDA Regulated) is strongly preferred
• Proven ability to demonstrate analytical capabilities (including statistical analysis, analytical capabilities etc.)
• Proven ability to demonstrate strong technical writing skills
• Knowledge of FDA QSR and ISO Quality Standards
• 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

Responsibilities

• Prepare metrics for routine quality reviews, Quality Compliance Council, and Management Reviews
• Follow up with Process Owners to ensure actions are being completed per the requirements of the quality system
• Establish reports to provide status on Quality activities
• Identify and communicate opportunities to improve the quality management system
• Participate in and/or lead the implementation of projects relating to Quality Compliance and other process improvement initiatives
• Develop project plans
• Provide project direction and support to project teams
• Monitor and report on project progress to appropriate stakeholders
• Perform other duties or special projects as assigned

Benefits

• Compensation: The anticipated salary range for this position is $93,000-$120,000 plus benefits
• This position also qualifies for up to 10% annual bonus based on Company, department, and individual performance

What This Job Offers

• Job Type: Full-time
• Industry: Administrative and Support Services
• Education Level: Bachelor's degree