Resonetics

Quality Engineer

Resonetics  •  Alajuela, CR (Onsite)  •  26 days ago
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Job Description

The Quality Engineer provides customer and factory facing quality support. The position includes managing the interface between Resonetics, its customers and suppliers quality organization, assisting with transition and sustaining of laser manufacturing processes, and support for our quality management system. The Quality Engineer position uses Quality Engineering techniques including: Problem solving using Lean Six Sigma methodology, Process Validations and Verifications, Process Development and optimization, Gage R&R, and reducing dependence on inspection along with ISO 13485 and/or 21CFR820 compliance.

Responsibilities

  • Liaising with customer quality personnel to resolve issues and Customer Complaints
  • Monitoring and disseminating customer quality report cards
  • Generating process deviations, Customer Change Notices, validation protocols & reports.
  • Assisting with troubleshooting of production processes Assisting with the PDP process
  • Leading development of metrology equipment
  • Developing and maintaining quality/control plans
  • Developing PFMECAs
  • Conducting Gage R&R studies
  • Resolving Corrective and Preventive Actions
  • Developing Quality Procedures and conducting training to all personnel as appropriate
  • Approving Nonconformance disposition
  • Analyzing production and validation data
  • Working on continual improvement and process assessment projects as assigned

Required Qualifications

  • Minimum 2 years experience in a Quality Engineering role in a regulated and/or start-up company, or equivalent engineering experience
  • Demonstrated technical writing and communication skills. Working knowledge of Statistical software and/or Minitab Bachelor's degree or equivalent experience

Preferred Qualifications

  • CQE and/or Six Sigma Green or Black belt
  • BS degree; Physics, Optics, Mechanical, Chemical, Plastics

Physical Demands

  • Light office work only; position may include up to 10% domestic and international travel
Resonetics

About Resonetics

Resonetics is a pioneer in advanced engineering and manufacturing solutions for the life sciences industry. Core capabilities include laser ablating, cutting, drilling and welding; nitinol shape setting and electropolishing, centerless grinding and photochemical machining, fiber optic sensing and thin wall tube fabrication. With Lightspeed Application Development Labs located strategically to serve MedTech companies around the world, Resonetics is built on a foundation of quality, speed and innovation to deliver best-in-class value with a customer centric approach.

For over 30 years, Resonetics has been a pioneer in micro manufacturing. Founded in 1987, Resonetics has continuously invested in leading edge technology to solve medical device manufacturing challenges and developing experts who innovate tomorrow’s medical devices. We have deployed over 500 laser workstations that cover a wide spectrum of laser types and wavelengths – femtosecond, picosecond, excimer, DPSS, and CO2. Combining state-of-the-art laser systems with a top technical team allows Resonetics to partner with customers and provide winning solutions that meet technical as well as economic requirements.

Resonetics has 14 manufacturing facilities located in the United States, Canada, Costa Rica, Israel and Switzerland with ISO-13485:2003 certified quality system and lean six-sigma practices.

Industry
Manufacturing & Production
Company Size
1,001-5,000 employees
Headquarters
Nashua, New Hampshire
Year Founded
1987
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