Quality Assurance Specialist

DeepHealth • Somerville, MA

8d • Hybrid

About The Position

The Quality Assurance Specialist is responsible for supporting DeepHealth products and product development, along with the Quality Management System throughout the organization. The Quality Assurance Specialist will be responsible for collaborating cross-functionally to support and guide product development. The Quality Assurance Specialist will work cross-functionally and within the team to support the Quality processes, such as QMS training, complaint and CAPA management.

Requirements

• Bachelor’s degree in relevant field (or equivalent experience, i.e. Associates Degree with 3 years of experience)
• Strong knowledge of FDA Quality System Regulations, including but not limited to, 21 CFR 11, and 21 CFR 820.
• 5 - 8 years working in a regulated industry (FDA and Software as a Medical Device preferred)
• Excellent written and oral communication skills

Nice To Haves

• Knowledge of EU Medical Device Regulation (MDR), ISO13485, ISO 14971, and IEC 62304 preferred.
• Knowledge and understanding of pre- and post- market clinical studies, including but not limited to, 21 CFR 812, 21 CFR 50, and 21 CFR 56, preferred but not required.
• Participation in regulatory audits a plus

Responsibilities

• Work cross-functionally with the Engineering, Clinical and Marketing teams to develop new products and implement design changes to existing DeepHealth products.
• Take ownership of product specific Quality Management System processes, such as CAPAs and complaint management, across the organization to ensure compliance and drive efficiency.
• Work cross-functionally to integrate products as a result of corporate and/or product acquisitions.
• Work as a team member with the Quality Assurance team to ensure compliance to US and OUS standards and regulations.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level