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.
Job requirements
Duties and responsibilities
As the Quality Assurance Specialist, this position will:
- Work cross-functionally with the Engineering, Clinical and Marketing teams to develop new products and implement design changes to existing DeepHealth products.
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.
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 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.
Work as a team member with the Quality Assurance team to ensure compliance to US and OUS standards and regulations.
Please Note: This is not an exhaustive list of all duties, responsibilities and requirements of the position described above. Other functions may be assigned, and management retains the right to add or change duties at any time.
Qualifications
Qualifications include:
- Bachelor’s degree in relevant field (or equivalent experience, i.e. Associates Degree with 3 years of experience)
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.
Strong knowledge of FDA Quality System Regulations, including but not limited to, 21 CFR 11, and 21 CFR 820.
- Knowledge of EU Medical Device Regulation (MDR), ISO13485, ISO 14971, and IEC 62304 preferred.
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.
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.
- 5 - 8 years working in a regulated industry (FDA and Software as a Medical Device preferred)
5 - 8 years working in a regulated industry (FDA and Software as a Medical Device preferred)
- Participation in regulatory audits a plus
Participation in regulatory audits a plus
- Excellent written and oral communication skillsWorking conditions
Excellent written and oral communication skills
Working conditions
This position may be based in the United States or India in a typical office setting.
This position will have the ability to work remotely and may require a flexible work schedule in order to support international teams.
Physical requirements
This position often requires sitting, standing, walking, bending, twisting, reaching with hands and arms, using hands and fingers, handling, or feeling, speaking, listening, and high-level cognitive thinking. Also, must be able to lift up to 10 pounds occasionally. The position requires the ability to travel (~10% of time), drive a vehicle, and utilize other forms of transportation.
- Somerville,Massachusetts,United States
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- AfghanistanAfghanistan
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