Quality Specialist

Quality Specialist - Medical Device Design & Development

RBC Medical Innovations is searching for a Quality Specialist who has QA experience in a medical device or equivalent environment. This position requires demonstrated organization and communication skills as well as a desire to continuously learn and engage with technical development teams and clients. You will be accountable for maintaining accurate electronic and paper quality assurance files, and increasing the effectiveness and efficiency of the processes for producing and maintaining them.  Our focus on producing life-saving devices requires someone with a proactive approach, who believes in commitment, enjoys a challenge and values a healthy work-life balance.

Duties and Responsibilities:

  • Taking ownership of preventing and resolving known issues within our work products
  • Assisting RBC’s Quality Manager with client and/or FDA quality requirements
  • Maintaining electronic and paper QA files
  • Inspecting documents for accuracy and compliance to FDA and ISO regulations
  • Assisting with ensuring validation for manufacturing quality processes
  • Conducting internal audits; reviewing and analyzing data and reporting results
  • Producing reports as needed or directed
  • Maintaining schedules of deadlines and progress
  • Tracking CAPA issues and progress
  • Closing out projects with support from Project Management and Accounting

In order to succeed in this role, candidates will have the following background & characteristics:

  • Technical proficiency in quality assurance techniques and best practices
  • Experience in a regulated QA environment, preferably with FDA QSR, med device, and ISO experience
  • Professional appearance and communication skills to facilitate successful interaction with clients and regulatory agencies, and effectively interpret and communicate information
  • Experience with ISO 13485 and/or 9001
  • Demonstrated ability to learn quickly and apply new concepts
  • Exceptional attention to detail, prioritization and organization skills
  • Flexibility in schedule to meet deadlines and produce results

RBC Medical Innovations: small-company culture with a commitment to excellence!

At RBC, we pride ourselves in our results-oriented culture and highly-qualified team of employees and we offer a competitive salary and rich benefits package,including:

  • Challenging, creative work environment
  • World-class team of engineers and designers
  • Flexible work schedule
  • Competitive benefits package

RBC Medical Innovations values a diverse team and is an Equal Opportunity Employer.  For more information, visit www.rbccorp.com.

No Agencies, please