• 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 QSR21 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 non-standard 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 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.
• 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.
• Bachelors 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.

$85,000-$130,000