[QUALITY] Quality Control Engineer

Company: Masimo Corporation
Location: Irvine
Posted on: April 5, 2021

Job Description:

Masimo (NASDAQ: MASI) headquartered in Irvine, California, is a fast-growing and award-winning international medical technology and device company with operations spanning the globe. We develop innovative, noninvasive monitoring technologies that save, extend and improve the lives of people of all ages, in all walks of life. These revolutionary technologies are helping to solve "unsolvable" problems that have plagued the healthcare industry, while taking the pain and discomfort out of blood monitoring. For more than 20 years, innovation has been and will continue to be our passion. The Quality Control Engineer is responsible for providing technical leadership and supervision for all aspects of quality control program to ensure continuous production of products consistent with established standards. Monitors and analyzes statistical data and product specifications to determine conformance of incoming raw materials, subassemblies, and finished products to established company requirements and specifications, and applicable industry standards. This position will handle multiple projects from product inception and development, through manufacture and customer use. The incumbent will also support all activities including but not limited to: design control activities, process validations, inspection and test, and equipment maintenance and calibration. Duties & Responsibilities

• Monitors and supervises the daily activities of the Quality Control/Assurance Technicians and Inspectors;
• Coordinates Incoming, In-Process, and/or Finished Goods Acceptance Testing for parts/ products;
• Generates, updates, and/or reviews process documents for release via the change order process and ensures that the inspection procedures are up to date;
• Leads and participates in problem solving activities related to design, manufacture and inspection and test, including CAPA, NCR and supplier related issues;
• Leads and participates in IQ/OQ and PQ activities, test sample size selection, test method validations, Gage R&R studies and risk management activities to assure conformance to product quality standards and applicable regulations;
• Monitors and controls the Non Conformance process, and participates in the MRB activities;
• Organizes and manages the Quality Control Records;
• Ensures that adequate inspection equipment is available, maintained, and calibrated;
• Provides support for internal and external audits and formulates response to audit findings and CAPAs;
• Prepares and reports QC metrics at QMS reviews;
• Monitors and supervises the maintenance & calibration coordination program and activities;
• Performs other duties or special projects as requested. Minimum Qualifications
  • Two or more years of experience with quality control process for inspection and testing of electronic components, subassemblies, and finished products;
  • Knowledge and experience working within a Quality Management System (QMS) in a regulated industry;
  • Hands on experience implementing and using statistical methods throughout various aspects of product realization, e.g., PFMEA, DFMEA, DOE and GR&R methodologies;
  • Knowledge of equipment calibration process and associated regulatory requirements
  • Excellent written and communication skills;
  • Ability to travel locally, domestically and internationally, as needed;
  • Good interpersonal skills dealing with peers and other functional areas;
  • Ability to work independently with minimum supervision. Preferred Qualifications
    • Prior experience in a Medical Device manufacturing environment;
    • Knowledge and experience with IPC 610, 620, IPC J-STD-001E, and MIL-T-31000/MIL-STD-100E;
    • Familiar with Part 820 Quality Systems Regulation;
    • Familiar with ISO-13485 requirements;
    • Proficient in utilizing Minitab for statistical data analysis;
    • Experience in Supervising Personnel. Education Bachelor's degree in engineering, manufacturing, or quality is required. Physical requirements/Work Environment This position primarily works in an office, laboratory, and manufacturing environment. It requires frequent sitting, standing and walking. Daily use of a computer and other computing and digital/mechanical devices is required. May sit or stand for extended periods. Must be able to regularly lift up to 35 pounds. Local, domestic, and international travel up to 20% of the time may be 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. We are proud to offer if eligible a highly competitive compensation plan with an excellent benefits package including 3 weeks vacation, stock options, 401k match, medical, dental, vision plans and much more! Masimo is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state or local law.

Keywords: Masimo Corporation, Irvine , [QUALITY] Quality Control Engineer, Engineering , Irvine, California