Quality Engineer III

Resonetics; Stony Hill (CT); On-site; USD 65,000 - 102,000; Full time

Job summary

Resonetics in Stony Hill, Connecticut is seeking a Quality Engineer III to apply advanced Quality Engineering practices in the medical device sector. You will lead initiatives aimed at enhancing quality control and guide projects with significant technical responsibility.

The ideal candidate will have over 2 years of experience in a similar role, familiarity with regulatory standards, and a Bachelor’s degree in Engineering. The position offers a competitive salary range of $65,000 - $102,000 per year.

Qualifications

• 2+ years of experience in a Quality Engineering role for a medical device manufacturer.
• Familiarity with ISO 13485 standards and FDA 21 CFR 820 regulations.
• Proven experience in creating job-related documentation.

Responsibilities

• Leads and contributes to new product introduction and process improvements.
• Conducts root cause investigations using problem-solving techniques.
• Mentors and teaches others in various technical capabilities.

Skills

Quality Engineering

Problem-solving

Technical writing

Statistical software

Risk management

Education

Bachelor's degree in Engineering or similar field

Tools

Minitab

Job description

Overview

Resonetics is a global leader in advanced engineering, prototyping, product development, and micro manufacturing, driving innovation in the medical device industry. With rapid expansion across all our locations, we continue to push the boundaries of technology while fostering a dynamic, employee-centered culture. Our commitment to excellence and continuous improvement makes Resonetics an exciting place for professionals passionate about shaping the future of micro-manufacturing and being part of something bigger.

This Quality Engineer IIIapplies 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/activities with moderate to high technical responsibility, complexity or strategic input; Acts as a subject matter expert in routine Quality Engineering and scientific matters; receives occasional, 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.

Responsibilities

• Demonstrateshighlevel ofproficiencyin applying various tools and methods toidentifyand realize newproductsor process introductions (ex. QMS, product related), and business improvements.
• Leads and contributes to the application of, and/or develops innovative applications for various risk management and risk mitigation tools and practices.
• Leads and/orcontributesto root cause investigations using various problem-solving techniques and tools and assesses effectiveness of corrective actions.
• Leads,conductsand supports the development of test methods in equipment, process, and product qualifications/validations.
• Develops, implements, and/ormaintainsprocess Quality control plansin accordance withproductutilizationand risk level andensures theyare followed.
• Develops, reviews, implements and/ormaintainsprocess controls usingappropriate techniquesand tools (ex.statisticalprocess controls, statistical inspection sampling).
• Support and ensure all levels ofregulatory requirementsper ISO 13485:2016 andFDA21 CFR 820 are beingutilized, in addition to other product regulatory requirements.
• Leads orparticipatesin design/technical reviews asappropriate.
• Lead QE on product development,sustainingand continuous improvementprojects.
• Act as a subject matter expert (SME) in at least 2 routine Quality areas.
• Partners with senior technical leaders (internal and external to the organization) to develop innovative approaches foridentifyingtechnical opportunities and quality improvements.
• Mentorsandteachesothers in various technical capabilities.
• Liaising with customer quality personnel to resolve issues and Customer Complaints.
• Generating process deviations, Customer Change Notices, validationprotocols& reports.
• Assisting with troubleshooting of production processes.
• Assistingwithproduction and product development processes.
• Leading development of metrology equipment.
• Developing andmaintainingquality/control plans.
• Ensuring Quality Management Systems procedures andappropriate regulationsand industry standards are beingutilizedthroughout the product development and process development processes.
• Developing Risk documentation in compliance with the QMS and regulatory standards, such as PFMEAs.
• 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
• Provides support or authors validation protocols for manufacturing and quality deliverables.
• Serves as the quality representative for Lightspeed projects, ensuring alignment with quality standards, risk mitigation, and process capability objectives.
• Support Equipment Calibration and Maintenance per applicable procedures.

Required Qualifications

• 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.
• Proven experience in creating job-related documentation for quality purposes.
• Demonstrated technical writing and communication skills.
• Working knowledge of Statistical software and/or Minitab.
• Bachelor’s degree in Engineering or similar field.
• Interact with customer and supplier companies in a professional manner; proactivelycommunicatewith them to ensure an ongoing two-way exchange of information.
• Auditing andqualificationof new suppliers may berequired.

Preferred Qualifications

• CQE and/or Six Sigma Green or Black belt
• BS degree:Biomedical,Mechanical,Engineeringpreferred
• Strong attention to detail and satisfactory organizational skills
• Able to self-manage project tasks

Physical Demands

• Standing and walking for short periods of time
• Ability to use a microscope, including manipulating small objects under a microscope

Compensation

The compensation for this role is competitive and will be based on experience and qualifications. The anticipated range is $65,000 - $102,000 per year.

For temp, temp-to-hire, and regular full-time positions, our company policy is that we are unable to provide visa sponsorship. Candidates must already be legally authorized to work in the United States without the need for sponsorship now or in the future.