Job Description

Madison Medical is committed to pioneering the medical and life science solutions of tomorrow. We are driven by a mission to make healthcare safer, healthier and more productive. Our businesses strive to enable positive impacts on health.

We are a group of businesses within one of the largest privately held companies in the world, Madison Industries; a safe haven for entrepreneurs who want to grow their businesses, a culture that encourages teammates to act with an owner’s mindset.

Our world class teams design and manufacture leading technologies in the medical, health care, pharmaceutical and bioscience industries. Madison Medical offers a comprehensive range of products that meet the demands of an ever-changing marketplace while improving millions of lives around the globe.

• Improving patient safety while helping to solve the nursing shortage.
• Faster, more accurate test results, so doctors can treat patients more effectively.
• Detecting cancer early to save more lives.
• Enabling those with skin conditions to live healthier, fuller lives.

Elevate Healthcare, a Madison Medical group company, is a leading innovator in the medical simulation industry. We specialize in developing advanced simulation technologies designed to enhance healthcare education and improve patient safety. Our products include a wide range of simulators for various medical fields, from ultrasound and surgical training to emergency and trauma care. Our mission is to make the world safer, healthier, and more productive by providing innovative solutions that elevate healthcare training, ultimately leading to better patient outcomes and a safer healthcare environment.

POSITION & REQUIREMENTS SUMMARY:

Join a rapidly growing company in the healthcare industry! As a key member of the Elevate Healthcare team, the Quality Engineer will work alongside internal teams and external partners to deliver high-quality products and services. This role will involve collaborating with various departments such as Engineering, Clinical Specialists, Product Management, Procurement, and Internal QA to drive and maintain top-notch quality performance. By leveraging quality tools, this individual will play an integral role in shaping and enhancing the quality culture at Elevate Healthcare.

RESPONSIBILITIES

Quality Management Systems (QMS) & Compliance

• Lead the development, implementation, and maintenance of the Quality Management System (QMS) to ensure compliance with industry standards and regulatory requirements.
• Conduct regular audits and assessments to ensure that all products and processes comply with relevant regulatory standards, including ISO 9001 and FDA regulations.
• Oversee the creation, review, and maintenance of quality documentation, including standard operating procedures (SOPs), work instructions, and quality manuals.
• Plan and conduct internal audits to evaluate the effectiveness of the QMS and identify areas for improvement, ensuring continuous compliance and quality enhancement.

Customer Satisfaction

• Oversee the complaint management process, including reviewing, investigating, and preparing responses to customer complaints, ensuring timely and effective resolution.
• Collect and analyze customer feedback to identify trends and areas for improvement, implementing changes to enhance customer satisfaction.
• Maintain open and effective communication with customers regarding quality issues, resolutions, and continuous improvement initiatives.
• Ensure the quality of customer service interactions by training and supporting customer service teams, setting quality standards, and monitoring performance.

Operations

• Manage supplier quality by overseeing the supplier approval process, conducting supplier audits, and ensuring the quality of incoming materials and components.
• Identify and implement process improvements to enhance product quality, reduce defects, and increase operational efficiency using Lean, Six Sigma, and other methodologies.
• Develop and oversee quality control procedures to ensure products meet established quality standards throughout the production process.
• Conduct root cause analysis for quality issues, implement corrective actions, and monitor the effectiveness of these actions to prevent recurrence.

Other

• Promote a culture of quality throughout the organization, encouraging all employees to prioritize quality in their work and contribute to continuous improvement.
• Develop and monitor key performance indicators (KPIs) related to quality, using data to drive decision-making and improvement initiatives.
• Provide training and development opportunities for employees on quality standards, tools, and best practices, fostering a knowledgeable and quality-focused workforce.
• Stay updated on industry trends, innovations, and best practices in quality management, and implement relevant strategies to keep the organization at the forefront of quality excellence.

REQUIREMENTS

• 1-2 years of experience leading personnel
• 3-5 years of experience as a quality engineering function working in an ISO9001 quality system
• Bachelor of Science degree in Engineering or pertinent technical discipline
• Strong analytical and problem-solving skills
• Demonstrated ability to make critical decisions, set priorities, and provide succinct direction in a dynamic manufacturing environment.
• Ability to communicate between various organizations and work with multifunctional teams, including leadership.
• Lean Six Sigma Certification: Knowledge of Lean Six Sigma methodologies for process improvement and efficiency.
• Project Management Skills: Capability to oversee projects through planning, execution, and monitoring.
• Proficiency in Microsoft applications, including Excel, PowerPoint, and Word, is required.

PREFERRED:

• Proficient in Salesforce and QPulse
• Proficient in ISO 9001 Quality Management Systems
• Process Mapping experience

GENERAL:

• Complies with and enforces all applicable safety rules, regulations and procedures both at Elevate Healthcare and wherever Elevate Healthcare is represented (i.e., program site, trade show, etc.).
• Performs other duties as assigned or as necessity dictates.

PHYSICAL REQUIREMENTS:

• Ability to lift or push weight up to 50 pounds (simulators).
• Ability to operate standard office equipment.

Elevate is an Equal Opportunity Employer and considers qualified applicants for employment without regard to race, color, creed, religion, national origin, sex, sexual orientation, gender identity and expression, age, disability, veteran status, or any other protected factor.

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