Product Development Quality Engineer III

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 employeecentered culture. Our commitment to excellence and continuous improvement makes Resonetics an exciting place for professionals passionate about shaping the future of micromanufacturing and being part of something bigger

Our Product Development Quality Engineer III 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/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 thats redefining medical device manufacturing. If youre passionate about innovation and thrive in a fastpaced environment wed love to hear from you.

• Demonstrates high level of proficiency in applying various tools and methods to identify and realize new products or 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/or contributes to root cause investigations using various problem solving techniques and tools and assesses effectiveness of corrective actions.
• Leads 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 utilization and risk level and are followed.
• Develops reviews implements and/or maintains process controls using appropriate techniques and tools (ex. Statistical process controls statistical inspection sampling).
• Support and ensure all levels of Design Controls per ISO 13485:2016 and QSR 21 CFR 820 are being utilized in addition to other product regulatory
  requirements.
• Leads or participates in design/technical reviews as appropriate. Lead QE on product development projects.
• Interprets and implements standard and nonstandard sampling plans. 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 for identifying technical opportunities and quality improvements.
• Mentors others in various technical capabilities.
• 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 processes.
• Assisting with production and product development processes. Leading development of metrology equipment.
• Developing and maintaining quality/control plans.
• Ensuring Quality Management Systems procedures and appropriateregulations 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.
• Support Equipment Calibration and Maintenance per the applicable procedures.

• Ability to create jobrelated 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 startup company or equivalent engineering experience.
• Demonstrated technical writing and communication skills.
• Working knowledge of Statistical software and/or Minitab.
• Bachelors degree or equivalent experience.
• Interact with customer and supplier companies in a professional manner; proactively communicates with them to ensure an ongoing twoway exchange of information. Auditing and qualification of new suppliers may be required.

The compensation for this role is competitive and will be based on experience and qualifications. The anticipated range is $78000$93000.