Cutera Cutera
Cutera.com

Quality Engineer

Brisbane, US

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Quality Engineer Brisbane, CA, US

Company description

We're Growing - With Growth Comes Opportunity!

About Cutera: Cutera is a leading global aesthetics device company with a comprehensive product portfolio and a global distribution footprint. We are a fast-paced, high-tech medical device company looking for the right person to help grow our business and reap the rewards of doing it! We hire the best people and provide them the best comp and benefits to help improve their lives. Read more at www.cutera.com

The Company’s technology enables physicians to provide advanced solutions for a broad range of medical aesthetic applications including improving the skin’s appearance through the treatment of superficial benign vascular and pigmented lesions, unwanted hair removal, improvement in skin laxity and wrinkles, and body contouring and sculpting.

Job Description

Summary:

The successful candidate will lead the manufacturing process improvement with the intent to gain efficiency and capacity improvements, cost reductions, improve sustainability, and maximize resource utilization. The person will work closely with Design engineers, Manufacturing engineers, Quality Technicians in manufacturing, test, and maintenance, as well as Sourcing Teams.

This dynamic role will be responsible for implementation of basic and advanced aspects of quality management systems such as NCR/MRB/CAPA/SCAR/FAI processes, performance metrics, internal audit processes, etc.

Duties and Responsibilities:

Assists the Quality Engineering Manager in coordinating and executing Quality objectives throughout the company in cooperation with cross-functional departments maximizing product quality and operating system efficiency/effectiveness while minimizing cost.

  • Experience with Metrology. CMM, Laser, Optical Measurement systems
  • Knowledge of Incoming Quality Control process
  • Thorough understanding of Geometric Dimensioning & Tolerancing
  • Understands Critical-to-Quality concepts
  • Investigate quality issues to identify root cause and implement corrective actions
  • Working knowledge of fixtures/gages design and error proofing technologies
  • Assist in the implementation of new technologies, tools, and systems to improve process efficiency and defect prevention
  • Assist Manufacturing with management of ERP system, testing, and manufacturing validation protocols
  • Author process flow charts, work instructions, quality alerts, and analysis reports
  • Develop data collection plans including test results analysis, define, implement, and communicate quality performance metrics throughout organization.
  • Assist engineering management in development/ coaching/ mentoring of junior engineers and technical staff in areas of component qualification, process qualification, and manufacturing processes.
  • Lead problem analysis and resolution efforts with production team
  • Conducts internal audits as required
  • Maintain current knowledge of medical and technical developments as related to company products.
  • Ensure that all regulatory and internal policies are followed.
  • Other duties as assigned

Qualifications

    Position Requirements:

    • Effective interpersonal, organizational, written and verbal communication skills.
    • Ability to understand technical drawings
    • Ability to effectively prioritize and accomplish work with minimal supervision.
    • Analytical and problem-solving skills.
    • Ability to manage multiple tasks in a fast-paced, deadline-driven environment.
    • Ability to work with changing priorities
    • BS or MS in Engineering or Physics, or equivalent experience
    • Three to five plus years of industry experience, preferably in medical devices
    • Knowledge of applicable international regulations and standards (ISO 13485, IEC 60601, and ISO 14971)
    • Auditing training & experience a plus
    • ASQ-CQE, LSS-BB certification or equivalent a plus.

    Additional information

    All your information will be kept confidential according to EEO guidelines.

    If you are ready to become part of our spectacular, growing, and FUN company, then apply today!

    We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status.

    We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, perform essential job functions, and receive other benefits and privileges of employment. Please contact us to request accommodation.

    Applicants responding to this posting must be able to provide proof of eligibility to work in the United States. Competitive salary, benefits, ESPP and stock options. Cutera is an Equal Employment Opportunity Employer.

    Job Location

    Department: Manufacturing/Operations

    City: Brisbane, CA, US

    Employer reference: REF659Y

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