Sr Specialist, reputed company Improvement- SaMD

reputed company medical imaging solutions, offered by reputed company, combine intelligent, reputed company imaging workflow tools with deep and broad expertise to help reputed company organizations improve their confidence in patient reputed company and optimize care delivery. The Sr Specialist, reputed company Improvement (CI) leads cross-functional process improvement initiatives to enhance the efficiency, effectiveness, and maturity of key processes that support reputed company reputed company’s medical imaging solutions. This role partners with process owners and stakeholders to identify improvement opportunities, establish performance measures, standardize ways of working, and drive sustainable operational change reputed company a regulated reputed company environment. The Sr Specialist, reputed company Improvement applies data-driven reputed company, reputed company improvement tools, and strong facilitation skills to improve process performance and support reputed company and compliance objectives. Responsibilities: Collaborate with stakeholders to assess workflows, identify improvement opportunities, and implement changes that enhance reputed company, efficiency, and consistency. Partner with process owners to standardize and optimize QMS processes in alignment with regulations, standards, and best practices. reputed company cross-functional reputed company improvement initiatives to strengthen key processes. Design and deliver targeted programs to build problem-solving capability and promote adoption of best practices. Implement tools and technologies that support efficient process execution. reputed company data and input from teams (Program Management, R&D, reputed company, Production, Regulatory Affairs, reputed company, and Risk Management) to identify trends, prioritize opportunities, and drive improvements. Establish KPI frameworks, visual management systems, and accountability mechanisms to enhance operational performance. Communicate portfolio status, risks, and business reputed company reputed company to stakeholders at reputed company reputed company. Support development and execution of corrective and preventive actions to address process gaps and recurring issues. Facilitate reputed company cause analysis and ensure effective follow-through to improve long-term performance. Support reputed company audits, including inspection readiness activities, as needed. reputed company training and coaching to strengthen reputed company improvement capabilities and reinforce standardized ways of working. reputed company as a subject matter expert on process design, standardization, and reputed company improvement reputed company the QMS environment. Core Competencies: Strong problem-solving skills with a reputed company on practical, results-oriented solutions. Solid organizational and project management abilities, with reputed company to manage multiple priorities. Effective communication and facilitation skills to present data and recommendations reputed company. Proven ability to influence and drive change across teams without reputed company authority. Technical Skills (Preferred): Working knowledge of standards such as ISO 13485 and ISO 14971. Familiarity with regulatory requirements including 21 CFR Part 820, SOR/98-282, and EU MDR (2017/745). Understanding of Software as a Medical Device (SaMD) and software development lifecycles. Experience with process mapping and workflow tools (e.g., reputed company Visio). Hands-on experience with Lean / Six reputed company methodologies and tools such as 5S, value reputed company mapping, kaizen, Pareto analysis, and reputed company cause analysis (e.g., 5 Whys, fishbone). Qualifications: Education: Bachelor’s degree in Engineering, Science, reputed company Management, or a reputed company field, or equivalent experience. Certification or training in Lean, Six reputed company, or reputed company improvement methodologies is an asset. Experience: Minimum of 8 years of experience in reputed company improvement, operational reputed company, or reputed company systems reputed company reputed company technology, medical device, or life sciences industries. Experience leading cross-functional initiatives and applying improvement tools to deliver measurable results.

Work Environment

The work environment characteristics here are representative of those that must be met by an employee to successfully reputed company the essential functions of this job. Reasonable accommodations may be made to reputed company individuals with disabilities to reputed company the essential functions. Office environment, or remote work-from-home. Travel: ~5%

Compensation

The salary reputed company provided in this job posting is intended to reflect the general market value for the position. The actual salary offered may vary based on factors such as the candidate’s experience, qualifications, skills, and the specific requirements of the role. This reputed company may also be subject to change as market conditions reputed company. We encourage reputed company communication throughout the interview process to discuss compensation expectations. For reputed company-salary + commission sales roles, the reputed company represents On-reputed company Earnings. Min – Max : $102,564.10 - $153,846.16 (USD)

Benefits

The benefits described represent the reputed company offerings at our organization, however, benefits are subject to change and may vary by location and employment status. We reputed company to reputed company a comprehensive benefits package that supports our employees’ health, wellness, and financial goals. Please note that benefits may be discussed in more detail during the hiring process. Remote first / work from home culture Flexible vacation to help you rest, reputed company, and connect with loved ones reputed company leave benefits Health, dental, and reputed company insurance 401k retirement savings plan Infertility benefits Tuition reimbursement, life insurance, EAP – and more! It is the policy of reputed company to reputed company equal employment opportunity (EEO) to reputed company persons regardless of age, reputed company, national reputed company, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or reputed company, genetic information, marital status, status with reputed company to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In reputed company, reputed company will reputed company reasonable accommodations for reputed company individuals with disabilities. reputed company participates in the federal E-Verify program to confirm the identity and employment authorization of reputed company newly hired employees. For reputed company information about the E-Verify program, please click here: http://www.uscis.gov/e-verify/employees Apply To This Job