Sr. Quality Assurance Specialist (PACS/RIS)

Rotterdam Innovation City; United States; Hybrid; USD 150,000; Full time

Job summary

A leading company in the medical device sector seeks a skilled Senior Quality Assurance Specialist. The ideal candidate will lead quality management processes and ensure compliance with FDA regulations. Based in Somerville, Massachusetts, the role offers flexibility for remote work and interaction with international teams.

Qualifications

• Minimum 5-8 years experience in regulated industries, preferably 8-10 years.
• Strong knowledge of FDA regulations and European Medical Device standards.
• Experience in regulatory audits is advantageous.

Responsibilities

• Lead quality processes for product development and regulatory compliance.
• Collaborate cross-functionally with Engineering, Clinical, and Marketing teams.
• Develop junior staff and monitor quality metrics for management review.

Skills

Communication

Quality Management

Regulatory Compliance

Education

Bachelor’s degree in a relevant field

Associate’s degree with 5 years experience

Tools

FDA Quality System Regulations

ISO 13485

IEC 62304

Job description

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 collaborate cross-functionally to support and guide product development. This role involves supporting quality processes such as QMS training, complaint handling, and CAPA management.

Job requirements

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

1. Actively engage cross-functionally within the organization, such as with 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, ensuring compliance with applicable standards and guidances.
3. Take ownership of product-specific Quality Management System processes, such as CAPAs and complaint management, to ensure compliance and improve efficiency.
4. Work cross-functionally to integrate products resulting from 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 of junior staff, as requested.
7. Monitor and collect quality metrics to support Management Review.

Qualifications include:

• Bachelor’s degree in a relevant field or equivalent experience (e.g., Associate’s degree with 5 years of experience).
• Minimum of 5-8 years (preferably 8-10 years) experience in a regulated industry, such as FDA-regulated or Medical Device sectors.
• Strong knowledge of FDA Quality System Regulations, including 21 CFR 11 and 21 CFR 820.
• Knowledge of EU Medical Device Regulation (MDR), ISO 13485, ISO 14971, and IEC 62304 is preferred.
• Understanding of clinical studies, including 21 CFR 812, 50, and 56, is a plus.
• Participation in regulatory audits is advantageous.
• Excellent communication skills, both written and oral.

Working Conditions:

This position can be based in the United States or India, in a typical office setting, with the possibility of remote work and flexible hours to support international teams.

Physical Requirements:

The role involves sitting, standing, walking, bending, reaching, handling, speaking, listening, and cognitive tasks. Occasional lifting of up to 10 pounds is required. Travel (~10%) and transportation use are also necessary.

Location: Somerville, Massachusetts, United States

Salary: $150,000 per year