Quality Engineer III

Resonetics•Bethel, CT

6d•$65,000 - $102,000

About The Position

The Quality Engineer III applies advanced Quality Engineering and scientific-method techniques and principles to daily work, applying relevant regulations, standards, and industry best practices. The role plans and conducts assignments and projects with moderate to high technical responsibility, complexity, or strategic input, and serves as a subject matter expert in routine Quality Engineering and scientific matters. The position receives occasional summarized instructions from technical Quality leaders and other functional stakeholders. The Quality Engineer supports product and process introductions, product development, sustaining work, validation, production troubleshooting, and continuous improvement. The role develops and maintains quality systems documentation and controls, manages risk and corrective-action work, supports regulatory compliance, collaborates with customers and suppliers, and mentors others in technical capabilities. It also serves as the quality representative for Lightspeed projects, supporting alignment with quality standards, risk mitigation, and process-capability objectives.

Requirements

At least 2 years of experience in a Quality Engineering role for a medical device manufacturer and/or start-up company, or equivalent engineering experience.
Familiarity with ISO 13485 standards and FDA 21 CFR 820 regulations.
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.
Ability to interact professionally with customer and supplier companies and proactively communicate with them.

Nice To Haves

CQE and/or Six Sigma Green Belt or Black Belt.
Bachelor of Science degree; Biomedical, Mechanical, or other Engineering discipline preferred.
Strong attention to detail and satisfactory organizational skills.
Ability to self-manage project tasks.

Responsibilities

Apply tools and methods to identify and realize new product or process introductions and business improvements.
Lead or contribute to risk management and risk mitigation activities, including developing innovative applications of relevant tools and practices.
Lead or contribute to root-cause investigations and assess the effectiveness of corrective actions.
Lead, conduct, and support development of test methods for equipment, process, and product qualifications and validations.
Develop, implement, and maintain process quality control plans according to product use and risk level, and ensure they are followed.
Develop, review, implement, and maintain process controls using appropriate techniques, including statistical process control and statistical inspection sampling.
Support compliance with ISO 13485:2016, FDA 21 CFR 820, and other applicable product regulatory requirements.
Lead or participate in design and technical reviews as appropriate.
Lead Quality Engineering work on product development, sustaining, and continuous-improvement projects.
Interpret and implement standard and non-standard sampling plans.
Serve as a subject matter expert in at least two routine Quality areas.
Partner with senior technical leaders inside and outside the organization to identify technical opportunities and quality improvements.
Mentor and teach others in technical capabilities.
Liaise with customer quality personnel to resolve issues and customer complaints.
Generate process deviations, Customer Change Notices, and validation protocols and reports.
Assist with production-process troubleshooting and production and product-development processes.
Lead development of metrology equipment.
Develop and maintain quality and control plans.
Ensure Quality Management System procedures and applicable regulations and industry standards are used throughout product- and process-development activities.
Develop risk documentation, such as PFMEAs, in compliance with the QMS and regulatory standards.
Conduct Gage R&R studies.
Resolve Corrective and Preventive Actions.
Develop Quality Procedures and conduct training for personnel as appropriate.
Approve nonconformance dispositions.
Analyze production and validation data.
Work on assigned continual-improvement and process-assessment projects.
Provide support for or author validation protocols for manufacturing and quality deliverables.
Serve as the quality representative for Lightspeed projects, ensuring alignment with quality standards, risk mitigation, and process-capability objectives.
Support equipment calibration and maintenance according to applicable procedures.
Create job-related quality documentation.
Communicate professionally with customer and supplier companies and maintain an ongoing two-way exchange of information.
Conduct audits and qualify new suppliers when required.