Sr. Quality Assurance Specialist (PACS/RIS)

DeepHealth; Somerville (MA); Hybrid; USD 70,000 - 110,000; Full time

Job summary

An innovative firm is seeking a Senior Quality Assurance Specialist to ensure product compliance and drive quality processes. This role involves collaborating with cross-functional teams to support product development and manage quality metrics. With a focus on FDA regulations and international standards, the ideal candidate will mentor junior staff and lead design changes, making a significant impact in a dynamic environment. Flexibility for remote work allows for a balanced work-life integration while contributing to essential quality management initiatives.

Qualifications

• 5-8 years experience in a regulated industry, preferably FDA and Software as a Medical Device.
• Strong knowledge of FDA regulations and ISO standards.

Responsibilities

• Engage cross-functionally to support product development and QMS processes.
• Lead design changes and ensure compliance with applicable standards.

Skills

FDA Quality System Regulations

Quality Management System (QMS)

CAPA management

Regulatory audits participation

Excellent communication skills

Education

Bachelor's degree in a relevant field

Associate's degree with 5 years of experience

Job description

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

As the Sr. Quality Assurance Specialist, this position will:

1. Actively engage cross-functionally within the organization, such as with the Engineering, Clinical, and Marketing teams, to develop new products within the Product Lifecycle Management (PLM) and New Product Introduction (NPI) processes.
2. Act as the Quality lead for design changes to existing DeepHealth products, including non-medical devices, to ensure compliance with the applicable standards and guidances.
3. Take ownership of product-specific Quality Management System processes, such as CAPAs and complaint management, across the organization to ensure compliance and drive efficiency.
4. Work cross-functionally to integrate products as a result of corporate and/or product acquisitions.
5. Collaborate with the Quality Assurance team to ensure compliance with US and international standards and regulations.
6. Participate in the development and mentoring of junior staff, as requested.
7. Monitor and collect quality metrics in support of Management Review.

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 include:

1. Bachelor’s degree in a relevant field (or equivalent experience, e.g., Associate’s degree with 5 years of experience).
2. Minimum of 5-8 years (8-10 years preferred) working in a regulated industry (FDA and Software as a Medical Device preferred).
3. Strong knowledge of FDA Quality System Regulations, including but not limited to, 21 CFR 11, and 21 CFR 820.
4. Knowledge of EU Medical Device Regulation (MDR), ISO 13485, ISO 14971, and IEC 62304 is preferred.
5. Understanding of pre- and post-market clinical studies, including but not limited to, 21 CFR 812, 21 CFR 50, and 21 CFR 56, is preferred but not required.
6. Participation in regulatory audits is a plus.
7. Excellent written and oral communication skills.

Working Conditions:

This position may be based in the United States or India in a typical office setting. It offers the flexibility of remote work and may require a flexible schedule to support international teams.

Physical Requirements:

This role often requires sitting, standing, walking, bending, twisting, reaching, using hands and fingers, handling, speaking, listening, and high-level cognitive thinking. Occasional lifting of up to 10 pounds is required. Travel (~10%) may be necessary, including driving and other transportation modes.