Quality Engineer I

Resonetics•Hutchinson, MN

70d•$56,000 - $84,000•Hybrid

About The Position

The Quality Engineer I provides customer and factory facing quality support. The position includes managing the interface between Resonetics, its customers and suppliers quality organization. This role assists with transitioning and sustaining laser manufacturing processes, and supports our quality management system. The Quality Engineer I 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. This role applies advanced Quality Engineering and scientific method techniques and principles to daily tasks and activities; applies relevant regulations, standards, and industry best practices to assignments; plans and conducts projects and assignments with moderate to high technical responsibility, complexity or strategic input; receives summarized instructions from technical Quality leaders at various levels in addition to other functional stakeholders. Join Resonetics and be part of a team that’s redefining medical device manufacturing. If you’re passionate about innovation and thrive in a fast-paced environment, we’d love to hear from you.

Requirements

0-2+ years’ experience in a Quality Engineering role for a medical device manufacturer and/or start-up company, or equivalent engineering experience.
Ability to create job-related documentation for quality purposes.
Demonstrated technical writing and communication skills.
Working knowledge of Statistical software and/or Minitab.
Bachelor’s degree or equivalent experience.

Nice To Haves

Familiarity with ISO 13485 standards and 21 CFR 820 regulations.
CQE and/or Six Sigma Green or Black belt.
BS degree: Physics, Optics, Mechanical, Chemical, Plastics, Engineering preferred.
Strong attention to detail and satisfactory organizational skills.
Able to self-manage project tasks

Responsibilities

Demonstrates strong proficiency in applying various tools and methods to identify and realize new product or process introductions (ex. QMS, product related), and business improvements.
Leads and contributes to the application of various risk management and risk mitigation tools and practices.
Leads and/or contributes to root cause investigations using various problem-solving techniques and tools and assesses effectiveness of corrective actions.
Conducts and supports the development of test methods in equipment, process, and product qualifications/validations.
Develops, implements, and/or maintains process Quality control plans are in accordance with product risk level and are followed.
Develops, implements and/or maintains process controls using appropriate techniques and tools (ex. Statistical process controls, statistical inspection sampling).
Supports all levels of Design Controls per ISO 13485:2016 and QSR 21 CFR 820.
Participates in design/technical reviews as appropriate.
Lead QE on product development projects.
Interprets standard and non-standard sampling plans.
May act as a subject matter expert (SME) in at least one routine Quality area.
Liaising with customer quality personnel to resolve issues and Customer Complaints
Generating process deviations, Customer Change Notices, validation protocols & reports.
Assisting with troubleshooting of production and product development processes.
Leading development of metrology equipment
Developing and maintaining quality/control plans
Ensuring Quality Management Systems procedures and appropriate regulations and industry standards are being utilized throughout the product development and process development processes.
Developing Risk documentation in compliance with the QMS and regulatory standards, such as 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.
Author protocols or provides support in performing qualification validation protocols in support of design control deliverables.
As a lead Quality Engineer on development projects, directly contribute and/or provide guidance to others to establish appropriate Design History File / Device Master Record documentation and provide detailed planning for product builds.