QA Manager

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

📋 Description

• Ensure that QMS processes such as Document Control, Complaint Management, Post-Market activities, CAPA, and Training comply with relevant quality and regulatory standards.

• Draft, revise, and assess quality documents, procedures, policies, and business processes to maintain ongoing compliance.

• Support and lead investigations into nonconformities, identifying root causes using suitable tools.

• Acquire product knowledge to make well-informed decisions that impact product quality and safety.

• Assist in audits by providing complete and accurate records in a timely manner.

• Work together with stakeholders to monitor and evaluate the successes and challenges of QMS processes.

• Implement enhancements to promote compliance, quality, and process efficiency.

• Engage in risk assessments, risk mitigation strategies, and risk management plans; provide review or approval as necessary.

• Aid in supplier, critical supplier, notified body, and other audits.

• Keep up-to-date with guidance documents, regulatory requirements, and industry best practices.

• Assist in various QMS areas as directed by the manager.

• Ensure compliance with the MIM Software Quality System and the MIM/GE HealthCare Quality Management System.

⛳️ Requirements

• Bachelor's degree from an accredited institution.

• A minimum of 7 years of relevant experience in Quality Assurance within a regulated environment, particularly in Medical Devices or Pharmaceuticals, ideally with Software as a Medical Device (SaMD).

• Proven understanding of Medical Device Quality Management System requirements and regulatory standards, including FDA CFR 21 820, ISO 13485, and MDSAP.

• Demonstrated experience in effectively leading and managing a team.

• Ability to collaborate efficiently and resolve conflicts.

• Legal authorization to work in the U.S.; employment visa sponsorship is not available at this time or in the future.

• Proficient knowledge of MIM’s product portfolios, Primary Products, and their classifications.

• Experience with QMS processes including Document Control, Complaint Management, Post-Market activities, CAPA, and Training.

• Familiarity with root cause analysis, risk assessments, risk mitigation strategies, and risk management plans.

• Capability to communicate quality and regulatory requirements to cross-functional teams.

• Strong critical thinking, problem-solving, root-cause analysis, and process improvement skills.

• Ability to manage multiple priorities and adapt to changes effectively.

• Initiative, strong time management skills, and the 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 opportunities for employee and company contributions.

• Life insurance.

• Disability insurance.

• Accident insurance.

• Tuition reimbursement.

• Opportunities for professional development.

• Relocation assistance is not provided.