Program Manager, Quality, AIS

This is a fully remote position, open to applicants in United States.

📋 Description

• Lead quality and compliance initiatives for AI-enabled medical devices, including Software as a Medical Device (SaMD).

• Ensure adherence to the relevant Quality Management System while promoting quality objectives and metrics.

• Offer quality supervision throughout new product introductions, design and development phases, design modifications, software launches, design transfers, and post-market activities.

• Assist in developing quality strategies, risk-based decision-making, verification and validation processes, and implementing design controls.

• Collaborate with software engineering, machine learning, clinical, regulatory, product, and program teams.

• Provide quality advice and convey complex quality and technical information effectively.

• Recognize and mitigate quality and compliance risks.

• Address quality challenges and facilitate investigations, nonconformances, CAPAs, audit resolutions, and continuous improvement efforts.

• Utilize cross-functional insights and internal resources to make informed decisions.

• Mentor and guide less-experienced team members.

⛳️ Requirements

• Bachelor’s degree from an accredited university or college, or a high school diploma/GED paired with a minimum of 10 years of experience.

• Over 6 years of relevant experience.

• Excellent oral and written communication abilities.

• Strong problem-solving and analytical skills.

• Capability to document, plan, market, and implement programs effectively.

• Proven project management expertise.

• Experience in supporting AI or machine learning-enabled medical devices, covering aspects such as data quality, model performance, traceability, validation, change control, and integration with medical device platforms.

• Background in quality assurance or design quality for medical devices, including SaMD.

• Familiarity with design controls, software lifecycle processes, risk management, verification, validation, and post-market quality activities.

• Legally authorized to work in the United States.

• Willingness to successfully complete a drug screening, if required.

🏝️ Benefits

• Performance-based incentive compensation, which may include cash bonuses and/or long-term incentives (LTI).

• Medical, dental, and vision insurance.

• Paid time off.

• 401(k) plan with opportunities for employee and company contributions.

• Life, disability, and accident insurance.

• Tuition reimbursement.

• Opportunities for professional development.

• Engaging and challenging career paths.

• Competitive compensation.