Quality Engineer

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 so that we all can Be Active and Stay Active. 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 currently recruiting for a hands-on Quality Engineer at Hyalex Orthopaedics. Working closely with our head of Quality and cross functionally across the organization, this role will support all facets of the design, development, manufacture, distribution, and post-market success of orthopaedic implants. Our ideal candidate is an innovative thinker, committed to Quality regulations and industry standards.

Hyalex is an ISO 13485 certified manufacturer located in Lexington, MA. This is an on-site position.

Role and Responsibilities

• Participate in product development team efforts under ISO 13485 Design Controls
• Maintain and improve the efficiency of the QMS through creating electronic workflows in company eQMS.
• Investigate the cause of customer complaints and other untoward events on a timely basis to bring to closure; work with external parties including sales and medical professionals to gather information and address root cause
• Perform internal and supplier audits or coordinate their outsourcing to qualified service providers in accordance with the audit plans.
• Assist hosting regulatory audits, including FDA and other regulatory agencies, and respond to audit findings using the CAPA system to document root-cause.
• Perform the inspection and/or testing of incoming inspection of goods, in-process assemblies or materials, and final test of finished devices including labeling inspections.
• Manage the calibration and PM of equipment including obtaining quotes, hosting service suppliers on site-visits, and shipping and receiving equipment and tools by mail. Updates equipment files as necessary.
• Review, ensure accuracy of, and archive records from manufacturing and cleanroom
• maintenance in the eQMS.
• Host environmental monitoring service suppliers and ensure conformance to internal Cleanroom SOPs on a periodic basis.
• Ensures timely initiation of NCMRs in response to discrepant products and processes, and hold MRBs to resolve any open NCMRs

Qualifications and Work Experience

• Bachelor's Degree in Engineering

• 2 or more years of industry experience in an Engineering role preferred; internships and coops will be considered.
• Knowledge of FDA Medical Device Regulations and the current ISO 13485 standard is preferred
• Knowledge of statistical data analysis, Minitab experience is preferred
• Experience using inspection hand tools is required, including scales, calipers, micrometers etc.
• Knowledge of sampling plans and statistical data analysis is preferred
• Experience using an electronic document management system such as Arena Solutions, or other PLM system is preferred.
• Excellent attention to detail and superior communication and writing skills
• Ability and willingness to work effectively with all levels of the organization
• Coursework in computer science, database administration, systems analysis and design preferred

Why Hyalex?

Hyalex values are focused on teamwork, communication, innovation, integrity, and accountability. All team members strive to promote as inspirations and productive workplace. Every team member's contribution is valued as we work towards a common goal of transforming Orthopaedics.

What we offer:

• Competitive compensation and generous stock options
• Comprehensive medical, dental and vision benefits
• Pre-tax savings plans for healthcare and childcare
• 401(k) retirement plan
• Generous paid time off (PTO)
• Short-term and long-term disability insurance and an employee assistance program
• Life Insurance
• Tuition reimbursement
• Paid parental leave
• The opportunity to work with driven and enthusiastic colleagues in a fast-paced and entrepreneurial environment, on problems that matter in a highly collaborative environment

The salary range for this position is $70,000 - $80,000 annually.

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 action 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.