Quality Assurance Specialist

Summary

Join DeepHealth as a Quality Assurance Specialist and contribute to the success of our products and product development. You will collaborate with cross-functional teams, including Engineering, Clinical, and Marketing, to develop new products and implement design changes. Responsibilities include managing Quality Management System processes like CAPAs and complaint management, ensuring compliance with US and OUS standards, and integrating products from acquisitions. This role requires a Bachelor's degree or equivalent experience and strong knowledge of FDA Quality System Regulations. The position offers the possibility of remote work and a flexible schedule to support international teams.

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
• 3 - 5 years working in a regulated industry (FDA and Software as a Medical Device preferred)
• Excellent written and oral communication skills

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

Preferred Qualifications

• Knowledge of EU Medical Device Regulation (MDR), ISO13485, ISO 14971, and IEC 62304
• 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
• Participation in regulatory audits

Benefits

• This position will have the ability to work remotely
• May require a flexible work schedule in order to support international teams