Sr. Quality Assurance Specialist (PACS/RIS)

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

Job summary

An innovative firm is seeking a Senior Quality Assurance Specialist to enhance product development and ensure compliance with quality standards. This role involves collaborating with cross-functional teams, leading quality processes, and mentoring junior staff. You'll play a vital role in managing the Quality Management System and ensuring adherence to FDA regulations and international standards. If you're passionate about quality assurance in a dynamic environment and want to make a significant impact in the healthcare industry, this opportunity is perfect for you.

Qualifications

• 5-8 years experience in a regulated industry, preferably FDA.
• Strong knowledge of FDA Quality System Regulations and compliance standards.

Responsibilities

• Engage cross-functionally to support product development and quality processes.
• Ensure compliance with applicable standards and manage quality metrics.

Skills

FDA Quality System Regulations

CAPA Management

Complaint Management

Communication Skills

Education

Bachelor's Degree in Relevant Field

Associate's Degree with 5 Years Experience

Job description

Senior Quality Assurance Specialist

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, working within the team to support quality processes such as QMS training, complaint management, and CAPA management.

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

1. Actively engage cross-functionally within the organization, including with Engineering, Clinical, and Marketing teams, to develop new products within the Product Lifecycle Management (PLM) and New Product Introduction (NPI) processes.
2. Serve 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. Collaborate across teams to integrate products resulting from corporate or product acquisitions.
5. Work 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 needed.
7. Monitor and report on quality metrics to support Management Review.

Note: This list is not exhaustive; other duties may be assigned or changed by management.

Qualifications

• Bachelor’s degree in a relevant field or equivalent experience (e.g., Associate’s degree with 5 years of experience).
• 5-8 years (8-10 preferred) of experience in a regulated industry, preferably FDA and Software as a Medical Device.
• 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 pre- and post-market, such as 21 CFR 812, 21 CFR 50, and 21 CFR 56, is a plus.
• Experience with regulatory audits is advantageous.
• Excellent communication skills, both written and oral.

Working Conditions

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

Physical Requirements

The position involves sitting, standing, walking, bending, reaching, handling, speaking, listening, and cognitive tasks. Ability to lift up to 10 pounds occasionally, travel (~10%), and operate transportation is required.