Join a team dedicated to supporting the crucial mission of improving health outcomes.
At Merative, you can apply your skills – and grow new ones – with colleagues who have deep expertise in health and technology. Merative provides data, analytics and software for the health industry. Our clients include providers, health plans, employers, life sciences companies and governments around the world. With industry-leading products and focused innovation, we help customers improve decision-making and performance so that together, we drive real progress in health. Learn more at merative.com
The Senior Specialist, Quality Engineering will play a critical role in ensuring the safety, quality, reliability and compliance of regulated and non-regulated medical imaging software devices. This position requires extensive experience in collaborating with cross-functional teams in design controls, safety and cybersecurity risk management, and human factors/usability. The ideal candidate will have a strong background in medical device design quality and a proven track record of driving continuous improvement.
Essential Job Duties
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Collaborates with cross-functional teams in the design and development of medical devices, ensuring compliance with design controls and safety risk management processes.
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Provide expertise and guidance in interpreting applicable regulations, industry standards, and Quality Management System (QMS) procedures.
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Collaborates with product development teams to drive product safety, quality, reliability, and compliance throughout the product lifecycle.
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Conducts risk assessments and develops risk management plans to mitigate potential safety issues.
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Assists with post-market activities, including Health Hazard Evaluations (HHEs), field corrections, and post-market surveillance, as necessary.
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Participates in internal and external audits and inspections, providing necessary documentation and support.
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Develops and tracks quality metrics to monitor performance and identify areas for improvement.
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Proactively identifies and resolves quality issues, implementing corrective and preventive actions as needed.
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Develops deliverables for regulatory submissions, as required, and ensures compliance with applicable regulations and standards.
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Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
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Drives continuous improvement initiatives to enhance product quality, safety, and compliance.
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Fosters a culture of excellence, collaboration, and continuous improvement across the organization.
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Participates in internal and external audits and inspections, as necessary.
Basic Qualifications
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Proven experience (5+ years) in healthcare technology, life sciences, or similar regulated industries, preferably with a focus on Software as a Medical Device (SaMD).
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Experience with design controls, safety risk management, and human factors/usability engineering.
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Excellent collaboration, problem-solving, critical-thinking, and decision-making skills.
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Strong organizational and project management skills, with the ability to prioritize and manage multiple tasks simultaneously.
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Excellent interpersonal, communication, and presentation skills.
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Ability to work independently with minimal supervision in a team setting.
Technical Skills
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In-depth understanding of applicable standards, including ISO13485, ISO14971, IEC62304, and IEC62366.
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Knowledge of applicable regulations, including 21 CFR Part 820, SOR/98-282, and 2017/745 EU Medical Device Regulation.
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Familiarity with software development lifecycles, including agile methods, and technology applications such as Jira, Aha!, Jama, and Microsoft 365.
Education Requirements
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Bachelor’s degree in a scientific or technical discipline required, or equivalent experience.
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Experience with agile development and cloud solutions preferred.
Work Environment
The work environment characteristics here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
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Office environment, or remote work-from-home.
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Travel: ~10%
It is the policy of Merative to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Merative will provide reasonable accommodations for qualified individuals with disabilities.
Merative participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here: http://www.uscis.gov/e-verify/employees
Top Skills
What We Do
Merative is a data, software and technology partner for the health and government social services industries, working with providers, health plans, employers, life sciences companies and governments.
With trusted technology and human expertise, the company works with clients to drive real progress. Merative helps clients orient information and insights around the people they serve to improve decision-making and performance.
Merative, formerly IBM Watson Health, became a new standalone company as part of Francisco Partners in 2022.
Learn more at merative.com
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