QA Manager
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Job Description
QA Manager overseeing QMS compliance for GE HealthCare medical device software. Leading audits, CAPA, document control, complaints, training, and quality improvements.
Responsibilities:
- Ensure QMS processes including Document Control, Complaint Management, Post-Market activities, CAPA, and Training meet applicable quality and regulatory standards
- Write, update, and review quality documents, procedures, policies, and business processes for ongoing compliance
- Assist and lead investigations of nonconformities and determine root causes using appropriate tools
- Develop product knowledge to make informed decisions influencing product quality and safety
- Support audits by promptly delivering complete and accurate records
- Collaborate with stakeholders to track and monitor QMS process successes and pain points
- Implement improvements to drive compliance, quality, and process efficiency
- Participate in risk assessments, risk mitigation strategies, and risk management plans; provide review or approval as needed
- Assist during supplier, critical supplier, notified body, and other audits
- Stay current with guidance documents, regulatory requirements, and industry best practices
- Assist in other QMS areas as directed by the manager
- Ensure adherence to the MIM Software Quality System and the MIM/GE HealthCare Quality Management System
Requirements:
- Bachelor's degree from an accredited university or college
- At least 7 years of relevant experience in Quality Assurance in a regulated industry, either Medical Devices or Pharmaceuticals, preferably with Software as a Medical Device (SaMD)
- Demonstrated understanding of Medical Device Quality Management System requirements and regulatory requirements, including FDA CFR 21 820, ISO 13485, and MDSAP
- Demonstrated experience in leading and managing a team effectively
- Demonstrated ability to collaborate effectively and resolve conflicts
- Legal authorization to work in the U.S.; employment visa sponsorship is not available now or in the future
- Proficient knowledge of MIM’s product portfolios and Primary Products and classifications
- Experience with Document Control, Complaint Management, Post-Market activities, CAPA, and Training QMS processes
- Knowledge of root cause analysis, risk assessments, risk mitigation strategies, and risk management plans
- Ability to communicate quality and regulatory requirements to cross-functional teams
- Critical thinking, problem-solving, root-cause analysis, and process improvement skills
- Ability to manage multiple priorities and navigate change
- Initiative, effective time management, and ability to work independently
Benefits:
- Performance-based incentive compensation, which may include cash bonuses and/or long-term incentives (LTI)
- Medical insurance
- Dental insurance
- Vision insurance
- Paid time off
- 401(k) plan with employee and company contribution opportunities
- Life insurance
- Disability insurance
- Accident insurance
- Tuition reimbursement
- Professional development
- Relocation assistance not provided
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