Engineer III, Quality
35 Days Old
The Quality Engineer III position at Masimo serves as a technical expert and leads quality projects across departments. An individual in this role will work as part of the Product Assurance department to help drive quality in the company's growing product portfolio. As an integral part of the product development team, quality engineers help guide and direct the team to produce quality products. As a result, a person in this position should be comfortable in all facets of quality engineering through all stages of a typical product lifecycle (Design, Verification and Validation Testing, Production, and Post-Market). A successful person in this role will exhibit the following: Excellence in working in a team environment, Strong engineering knowledge, Good understanding of quality engineering, Commitment to a career in quality, Ability to take on and overcome challenges, and have a general interest in improving products and processes.
Duties & Responsibilities:
- Support the Product Assurance goal of driving making quality a competitive advantage;
- Maintain up to date knowledge of Quality System Regulations (FDA CFR 21 820), ISO 13485, Canadian Medical Device Requirements (CMDR), MDD 93/42 EEC and other applicable international medical device standards and regulations.
- Collaborates with R&D to qualify new products to design control requirements.
- Participate in problem solving activities related to design, manufacture, inspection, and test, including CAPA, NCR and supplier related issues.
- Lead investigations of major nonconformances and systemic issues.
- Participates in in the improvement of product and manufacturing quality and reliability through tools appropriate for the project, such as test sample size selection, test method validations, Gage R&R studies, and SPC.
- Contribute as part of multi-departmental teams in product and process risk analysis and risk management activities, including the development and maintenance of product and process FEMA and Risk Analysis reports.
- Mentors junior engineers and provide technical guidance.
- Drive process validation and continuous improvement initiatives.
- Ensures robust application of the quality system by supporting the entire Quality Management System including the CAPA, NCR, customer feedback activities, and product failure analysis;
- Develop and improve quality systems and procedures;
- Develop and maintain Design History Files (DHF) for products;
- Perform other duties or special projects as requested.
Minimum & Preferred Qualifications and Experience:
Minimum Qualifications:
- 5-7 years of Quality Engineering/Quality Assurance experience;
- 4 years' experience in a medical device design, development, and manufacturing environment;
- Direct experience with ISO 13485 and FDA QSRs;
- Direct experience in Test protocol development and execution in support of new product development and/or failure analysis;
- Hands on experience implementing and using statistical methods throughout various aspects of product realization, including use of PFMEA, DFMEA, DOE and GR&R methodologies;
- Strong communication, documentation, problem solving and teamwork skills;
- Ability to occasionally travel domestically and internationally;
- Proficiency with Microsoft Office applications;
- Prior experience with PLM, MMS, ERP systems;
Preferred Qualifications:
- Certified Quality Engineer (CQE)
- Experience with sterilization validations
Education:
- B.S. in Electrical Engineering, Biomedical/Biomechanical Engineering, or a related science/engineering discipline is required.
- M.S. in a related Engineering or science discipline is a plus.
Compensation
The anticipated salary range for this position is $90,000 - $120,000 plus benefits. Actual placement within the range is dependent on multiple factors, including but not limited to skills, education, and experience. This position also qualifies for up to 10% annual bonus based on Company, department, and individual performance.
Masimo offers benefits such as 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, wellness clinic, Fitness Center, and Cafe. All benefits are subject to eligibility requirements.
- Location:
- Irvine
