Senior Quality & Compliance Engineer

Paige AI; Remote (OR); Remote; USD 119,000 - 140,000; Full time

Job summary

Join a forward-thinking company as a Senior Quality & Compliance Engineer, where you'll play a crucial role in ensuring the highest standards of quality for medical device software. This position offers the opportunity to lead risk assessments, collaborate with cross-functional teams, and maintain compliance with essential regulations like IVDR and ISO 13485. You'll be part of an innovative environment that values diverse perspectives and fosters a culture of trust and collaboration. If you are passionate about quality engineering and looking to make a significant impact in the medical device industry, this role is perfect for you.

Qualifications

• Bachelor's degree in relevant field and 3 years of SaMD quality systems experience required.
• ISO 13485 certification and strong analytical skills are essential.

Responsibilities

• Lead risk assessments and ensure compliance with IVDR and ISO 13485 standards.
• Collaborate with teams to maintain a robust quality management system.

Skills

Internal Audits

External Audits

Software Validation

Problem-Solving

Analytical Skills

Project Management

Education

Bachelor's degree in Biomedical Engineering

Bachelor's degree in Software Engineering

ISO 13485 Certificate

Tools

Agile Methodologies

Project Management Tools

Job description

Job Title: Senior Quality & Compliance Engineers

Employer: Paige.AI, Inc.

Job Location: 11 Times Square, Floor 37, New York, New York 10036

Telecommuting is available for this position. Candidate must be willing to travel to New York, New York up to 3 times per year for a period of one week per visit. No more than 10% domestic travel required per year.

Job Duties:

• Develop and maintain an in-depth understanding of the In Vitro Diagnostic Regulation (IVDR) and its specific requirements related to medical device software components to ensure compliance;
• Lead risk assessment activities related to software development used in medical devices, including hazard analysis, risk management plans, and mitigation strategies;
• Collaborate with cross-functional teams to establish and maintain a robust quality management system (QMS) of medical devices that complies with IVDR and other relevant standards, such as ISO 13485;
• Investigate and resolve quality issues through root cause analysis, implement corrective and preventive actions (CAPA), and address non-conformance issues;
• Write detailed operating procedures and work instruction-level documents for the QMS;
• Identify opportunities for process improvements and best practices in software quality engineering and implementation;
• Prepare for and support regulatory audits and inspections related to IVDR and other quality standards and manage audit and inspection readiness projects;
• Prepare and maintain documentation necessary for regulatory submissions, including technical files and design dossiers, while ensuring project documentation is up to date.

Requirements:

Employer requires candidate to have at least a Bachelor's degree in Biomedical, Software, Chemical, Processing, Systems, or Quality and Compliance Engineering, or a closely related field, and three (3) years of work experience as a Software as a Medical Device (SaMD) quality systems engineer or closely related occupation. Employer also requires candidate to have an ISO 13485 certificate.

Candidate must also have the following:

• Demonstrated ability conducting and leading internal audits and leading external audits within a Software as a Medical Device (SaMD) regulated environment gained through two (2) years of work experience;
• Demonstrated ability working within software methodologies (e.g., agile practices), software validation, and project management tools gained through two (2) years of work experience;
• Demonstrated ability working within quality regulations and standards relevant to medical devices, including 21 CFR 820, EU IVDR 2017/746, MDSAP, and CMDR SOR/98-282, gained through two (2) years of work experience;
• Demonstrated ability applying problem-solving and analytical skills to investigate root causes and resolve quality issues, analyzing and implementing corrective and preventive actions (CAPA), and addressing non-conformances (NC) and internal/external audit findings gained through two (2) years of work experience;
• Demonstrated knowledge of In Vitro Diagnostic Regulation (IVDR) gained through at least one year of work experience;
• Demonstrated project management ability, including risk management, quality management, and regulatory submissions, gained through at least two (2) years of work experience.

All years of experience may be gained concurrently.

Salary: $119,789 to $139,789 USD per year.

Applicants can send resumes to Paige.AI, Inc. via Greenhouse, or by mailing applications to Christina Segro, Paige.AI, Inc., 11 Times Square, 37th Floor, New York, NY 10036.

Paige.AI is an equal opportunity employer. We are committed to building an inclusive and collaborative work environment that fosters trust, amplifies diverse perspectives, and empowers innovation. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, color, religion, sex, pregnancy, gender identity, sexual orientation, parental status, national origin, age, disability, genetic information (including family medical history), political affiliation, military service, or any other status protected by the laws or regulations in the locations where we operate. We encourage candidates from all backgrounds and experiences to apply.

To request a reasonable accommodation, please let us know in your application or email us at [e-mail]

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