Sr Specialist, Quality & Continuous Improvement

Join a team dedicated to supporting the crucial mission of improving health outcomes.

At Merative,  you can apply your skills – and grow new ones – with colleagues who have deep expertise in health and technology. Merative provides data, analytics and software for the health industry. Our clients include providers, health plans, employers, life sciences companies and governments around the world. With industry-leading products and focused innovation, we help customers improve decision-making and performance so that together, we drive real progress in health. Learn more at merative.com

Merge medical imaging solutions, offered by Merative, combine intelligent, scalable imaging workflow tools with deep and broad expertise to help healthcare organizations improve their confidence in patient outcomes and optimize care delivery.
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. The Quality & CI Specialist is responsible for ensuring the ongoing efficiency and effectiveness of QMS processes, and for ensuring compliance with applicable regulations and industry standards. 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.

Quality Management Systems (QMS)

· Develop, implement, maintain, 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 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.

Continuous Improvement (CI)

· 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.

Other duties as required.

Core Competencies:

· Strong problem-solving skills with a focus on practical solutions and continuous improvement.

· Good organizational skills with the ability to handle multiple priorities and work well in a team environment.

· Strong communication skills, including the ability to present information clearly and concisely.

· Proven ability to collaborate effectively with cross-functional teams.

Technical Skills, (if applicable):

· 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.

Qualifications Required:

a) Education Requirements:

· 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.

b) Experience

· 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.

Work Environment:

The work environment characteristics here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

· Office environment, or remote work-from-home.

· Travel: ~5%

It is the policy of Merative to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Merative will provide reasonable accommodations for qualified individuals with disabilities.