Compliance and Quality Manager (SaMD)

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We are seeking a highly skilled and experienced Compliance and Quality Manager to join our team. This role will be responsible for ensuring that our software products, some of which include artificial intelligence and some that are regulated as medical devices by the FDA, meet all regulatory requirements and quality standards. This role involves overseeing the entire quality management system, including compliance with FDA regulations, ONC HTI-1 regulations, risk management, and continuous improvement initiatives. This position will also provide quality management support to the WellSky Responsible AI Committee, overseeing quality standards for development and deployment of software features that incorporate artificial intelligence.

SaMD experience HIGHLY preferred!

We invite you to apply today and join us in shaping the future of healthcare!

Key Responsibilities

• Ensuring certain software products comply with FDA regulations, ONC HTI-1, and other relevant standards. Staying updated on changes in regulations and implementing necessary adjustments to maintain compliance.
• Developing, implementing, and maintaining the QMS in accordance with FDA requirements and ISO 13485 standards. Ensuring that all processes are documented and followed.
• Conducting risk assessments and implementing risk mitigation strategies to ensure the safety and effectiveness of software products. Maintaining a risk management file and ensuring it is up-to-date.
• Planning and conducting internal audits to ensure compliance with QMS and regulatory requirements. Identifying areas for improvement and implementing corrective actions.
• Evaluating and qualifying suppliers to ensure they meet quality standards. Conducting regular audits of suppliers and managing supplier performance.
• Developing and delivering training programs for employees on quality management and regulatory requirements. Ensuring that all employees are aware of their roles and responsibilities in maintaining product quality.
• Leading continuous improvement initiatives to enhance product quality and process efficiency. Implementing best practices and driving a culture of quality throughout the organization.
• Investigating and managing quality incidents, including non-conformance and customer complaints. Developing and implementing corrective and preventive actions to prevent recurrence.

Required qualifications

• Bachelor’s degree in Engineering, Quality Management, or a related field
• 5 years of experience in medical device quality management, compliance, or related fields

Preferred qualifications

• Master’s degree or professional certification (e.g., Certified Compliance & Ethics Professional, Certified Risk Manager, Certified Quality Engineer, Certified Quality Manager)
• Experience in supporting software development in the context of the FDA medical device regulations or development of software features incorporating artificial intelligence

WellSky is where independent thinking and collaboration come together to create an authentic culture. We thrive on innovation, inclusiveness, and cohesive perspectives. At WellSky you can make a difference.

WellSky provides equal employment opportunities to all people without regard to race, color, national origin, ancestry, citizenship, age, religion, gender, sex, sexual orientation, gender identity, gender expression, marital status, pregnancy, physical or mental disability, protected medical condition, genetic information, military service, veteran status, or any other status or characteristic protected by law. WellSky is proud to be a drug-free workplace.

Applicants for U.S.-based positions with WellSky must be legally authorized to work in the United States. Verification of employment eligibility will be required at the time of hire. Certain client-facing positions may be required to comply with applicable requirements, such as immunizations and occupational health mandates.

Here are some of the exciting benefits full-time teammates are eligible to receive at WellSky:

• Excellent medical, dental, and vision benefits
• Mental health benefits through TelaDoc
• Prescription drug coverage
• Generous paid time off, plus 13 paid holidays
• Paid parental leave
• 100% vested 401(K) retirement plans
• Educational assistance up to $2500 per year

WellSky provides equal employment opportunities to all people without regard to race, color, religion, sex, national origin, ancestry, marital status, veteran status, age, disability, sexual orientation or gender identity or expression or any other legally protected category.

 

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