[Hiring] Senior Specialist, Quality & Continuous Improvement @Merative

Role Description

The Quality & Continuous Improvement (CI) Specialist leads the implementation, maintenance, and continuous improvement of Merge Healthcare’s Quality Management System (QMS) to enable successful delivery of the company’s medical imaging solutions. This role requires strong leadership and collaboration skills with the ability to influence change and drive operational excellence in support of Merge Healthcare’s quality objectives.

• Develop, implement, maintain, and continually improve an efficient and effective Quality Management System (QMS) to meet the requirements of applicable regulations, standards, and industry best practices.
• Implement key QMS processes such as Audit, CAPA, Change Control, Document Control, Training, and Supplier Management.
• Proactively identify areas for improvement and implement corrective and preventive actions.
• Facilitate root cause analysis and lead quality improvement initiatives to prevent recurrence of known issues.
• Lead the planning and execution of internal audits and supplier audits, as required.
• Prepare for and participate in external audits and inspections with Auditing Organizations and regulatory authorities, as necessary.
• Provide training to cross-functional teams to promote a culture of quality and create awareness of compliance across the organization.
• Provide subject-matter expertise and advise cross-functional teams on the implementation of the QMS.

• Plan, lead, and execute continuous improvement initiatives in collaboration with cross-functional teams.
• Plan, implement, and deploy tools and technologies to support the implementation of efficient and effective processes.
• Collaborate with key stakeholders to identify opportunities for improvement, analyze workflows, drive targeted improvements, enhance quality, and reduce waste.

Qualifications

• Bachelor’s degree in Engineering, Science, Quality Management, or a related technical field, or equivalent education and experience.
• Certification or formal training in Lean Manufacturing/Six Sigma is an asset.
• Minimum of 8 years of experience in quality management or related roles within the healthcare technology or life sciences industry.
• Experience in leading or facilitating CI initiatives and applying a range of continuous improvement tools and techniques.

Requirements

• Understanding of relevant standards, including ISO13485 and ISO14971 preferred.
• Familiarity with regulatory requirements such as 21 CFR Part 820, SOR/98-282, and 2017/745 EU MDR is preferred.
• Knowledge of Software as a Medical Device (SaMD) concepts and software development lifecycles is preferred.
• Experience with quality management tools and software, such as MasterControl and Microsoft Visio for process mapping and diagramming.
• Experience in applying Lean/Six Sigma tools preferred e.g., 5S, Value Stream Mapping, Kaizen, Pareto Charts, Root Cause Analysis (fishbone diagram, 5 Whys), and Lean principles such as waste reduction.

Benefits

• Remote first / work from home culture
• Flexible vacation to help you rest, recharge, and connect with loved ones
• Paid leave benefits
• Health, dental, and vision insurance
• 401k retirement savings plan
• Infertility benefits
• Tuition reimbursement, life insurance, EAP – and more!