This QE 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.

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.

•  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 process
• 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.
• Support Equipment Calibration and Maintenance per the applicable procedures.

• Ability to create job-related documentation for quality purposes.
• Familiarity with ISO 13485 standards and 21 CFR 820 regulations.
• Minimum 2 years’ experience in a Quality Engineering role for a medical device manufacturer 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.
• Interact with customer and supplier companies in a professional manner; proactively communicates with them to ensure an ongoing two-way exchange of information. Auditing and qualification of new suppliers may be required.

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

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

The compensation for this role is competitive and will be based on experience and qualifications. The anticipated range is $65,000-$81,000.

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.

Resonetics will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.