Senior Quality Engineer

We are looking for an experienced and detail oriented Senior Quality Engineer to join our growing team and support new product development activity for the Quality Assurance department in a dynamic and complex engineering environment. This role is based full time in our Burlington, MA office.

RESPONSIBILITIES

  • Represent Quality Engineering during design phase activity including development, verification, validation, transfer, and associated design reviews (new product development and product realization)

  • Participate in risk management activity - analysis and documentation applied throughout the product development process

  • Support the design engineering teams for software, data science, and hardware/systems throughout the design control process and Software Development Life Cycle (SDLC)

  • Support sustaining engineering through operational quality activity - material control, process development, inspection/acceptance activity, nonconforming material control, equipment qualification, and supplier management

  • Inspect and test materials, equipment, processes, and products to ensure quality specifications are met

  • Design and implement quality system processes to comply with regulatory standards

  • Cross-functional personnel training for quality and compliance best practices and mentoring QA team members

  • Support internal audity activity, including preparation and readiness for external ISO 13485 certification

  • Own expanding understanding of applicable external standards to scale compliance in preparation for product commercialization

SKILLS AND EXPERIENCE

  • Bachelor’s degree in mechanical or biomedical engineering or related applicable engineering field

  • A minimum of 8 years experience in quality engineering or related role in a regulated industry

  • Experience in software, data science, hardware/systems design and production or with similar medical devices, while working within a Quality Management System

  • Applied understanding of 21 CFR 820, ISO 13485:2016, and IEC 62304:2006

  • Demonstrated experience in the product development lifecycle, SLDC, design controls, and risk analysis

  • Excellent communication skills, good documentation practices (formal protocols and reports), attention to detail, and project management skills

For inquiries or to submit your resume, email us at jobs@coremapmedical.com and reference the job posting in your email title.

Leah Trocchi