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.
We are seeking a co-op candidate to work directly with our Quality team supporting the product development and work within the eQMS system. This position will work on-site in our Lexington facility and reporting directly to the Quality Engineer II.
Role and Responsibilities:
- Assist in the analysis, implementation, and maintenance of Quality Management System (QMS) processes, including Training, Supplier Control, Production Controls, CAPAs, Complaints, Design Control, Post-Market Surveillance, Recalls, and Management Review
- Initiate and maintain quality processes including CAPA, NCMR, and Manufacturing Work Orders
- Inspect incoming materials/ components and document within the electronic Quality Management System (eQMS)
- Manage assets and equipment records, including calibration and preventative maintenance
- Draft and document procedures to align with company activities and best practices
- Create items, Suppliers, Change Orders, and other workflows in the eQMS
- Execute the transformation from legacy paper documentation to new electronic records
- Other duties, as assigned
Qualifications/Work Experience:
- Significant coursework toward a B.S. Degree in Science, Engineering, or Technology
- Coursework in computer science, database administration, statistical data analysis, systems analysis and design is preferred
- Some knowledge of statistical data analysis is preferred
- Some knowledge of /familiarity with ISO 13485 and 21 CFR 820 preferred
- 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 with all parts of the organization from CEO to entry-level trainees, technical and non-technical
Skills/Experience
- Quality Systems
- ISO 13485
- 21 CFR 820
- CAPA, NCMR
- Statistical data Analysis
- Asset Management
- Preventative maintenance
Why Hyalex?
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.