Quality Engineer

Hyalex Orthopedics is seeking candidates to be a key member of the Hyalex team supporting many facets of the product development effort and Quality Management System effectiveness. You will also interface with representatives of regulatory agencies and suppliers while representing Hyalex in a professional capacity. This role will report to the VP of Quality.

Role and Responsibilities

  • Assist product development team efforts under ISO 13485 Design Controls
  • Assist in the management, improvement, and maintenance of the QMS processes including Training, Supplier Controls, Production controls, Document Controls, CAPA, Complaints, Design Controls, Post-Market Surveillance, Recalls, and Management Review.
  • Host regulatory audits and respond to audit findings using the CAPA system to document root-cause,
  • Assist users in the eQMS system,
  • Other duties as assigned

Qualifications/Work Experience

  • B.S. Degree in Science, Engineering, or Technology
  • Coursework in computer science, database administration, statistical data analysis, systems analysis and design is preferred
  • 2 years’ experience in a medical device design, development, manufacturing environment. Experience at companies in a highly regulated field such as aerospace will be considered.
  • Knowledge of FDA Medical Device Regulations and the current ISO 13485 standard is preferred
  • Knowledge of statistical data analysis
  • Experience using an electronic document management system such as Arena Solutions, Agile, Documentum, Master Control, or other PLM system is preferred
  • Excellent attention to detail
  • Superior communication and writing skills
  • Ability and willingness to work effectively with all parts of the organization from CEO to entry-level trainees, technical and non-technical

Why Hyalex?

Hyalex Orthopaedics is an award winning, venture funded medical device start-up developing transformational synthetic cartilage technology and implant systems for diseased and damaged joints. We address unmet clinical needs to improve patient quality of life. Our Hyalex team is comprised of industry leaders, innovators, and experts who have developed and launched many successful commercial products as well as a team of brilliant engineers, scientists and medical professionals.

Hyalex values are focused on teamwork, communication, innovation, integrity, and accountability and all team members strive to promote an inspirational and productive workplace. Every team member’s contribution is valued as we work towards a common goal of transforming orthopaedics.

The health and safety of our team members is our primary concern, especially during the COVID-19 pandemic. Beyond compliance with all local, state and national requirements we have taken additional measures to support the safety of our on-site operations and personnel in Lexington, MA.

Important notice to Employment businesses/ Agencies

Hyalex does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact the Hyalex human resources department to obtain prior written authorization before referring any candidates. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and Hyalex. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of Hyalex. Hyalex shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site