Location: Waukesha,WI, USA
Job Description SummaryAs Director - QA / Senior Director - QA, you will be part of the Central Q&R Organization. You will be responsible for the implementation and sustenance of Quality Management System and driving improvements within the Commercial organization including Channel Partners / Service Providers.Develop and maintain systems, rules, and processes to ensure fulfillment of internal and external requirements. Ensures that projects and products are capable and will meet specified standards (Preventive). Interprets simple internal and external business challenges and recommends best practices to improve products, processes or services. Stays informed of industry trends that may influence work.GE HealthCare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.Job DescriptionRoles and ResponsibilitiesCreates a Quality culture by driving compliance activities in the region. This includes being responsible for the total Quality Management System for the business and driving Quality metrics. Ensures quality and regulatory compliance while driving process effectiveness and efficiency. Represents GE HealthCare to external agencies and champions the evolution of the quality culture which includes executing and driving quality objectives, metrics, reporting and operating mechanisms.Requires specialized depth and/or breadth of expertise within their discipline. May require strong commercial awareness, and is expected to influence the development of strategy working with Channel Partners and Service Providers.Develop and implement processes and procedures for qualification, onboarding and monitoring / audit of Channel Partners and Service Providers. Implement QMS with external partners that is compliant with regulatory requirements.Problem solving, identifying root cause, implementing corrective actions and ensuring sustenance.Will lead functional teams or projects with moderate to high resource requirements, risk, and/or complexity to drive continuous improvement within the quality system.Presents business solutions to leaders in the area of quality including Recalls, CAPA, Quality Metrics, etc. Communicates complex messages and negotiates mainly internally with others to adopt a different point of view. Influences peers to take action and negotiate with external partners.Impacts the team's ability to achieve service, quality and timeliness of objectives. Work is subject to functional policy objectives. Regularly advises management in the function and/or in the business. Has a supportive role in decision making about important subjects. High levels of evaluative judgment are required to achieve outcomes required.Uses high level of judgment to make decisions and handle complex tasks or problems that impact the function. Has ability to assess quality of information given and ask pertinent questions to stakeholders. Able to offer new solutions to problems outside of set parameters and is able to construct and provide recommendations. Uses multiple internal and some external sources outside of own function to help arrive at a decision.Required QualificationsMinimum of Bachelor's Degree from an accredited university or collegeMinimum 12 years' experience in Quality Assurance / Regulatory AffairsDesired CharacteristicsStrong oral and written communication skills.Experience leading and implementing change.Demonstrated understanding or aptitude to understand Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820 and ISO 13485.Strong interpersonal and leadership skills.Demonstrated ability to analyze and resolve problems.Demonstrated ability to lead programs / projects.Ability to document, plan and execute programs.Established project management skills.Prior experience as a Site QA LeaderStrong auditing skills, certified ISO 13485 Lead AuditorWe expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership –always with unyielding integrity.Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you'd expect from an organization with global strength and scale, and you'll be surrounded by career opportunities in a culture that fosters care, collaboration, and support.#LI-MC2For U.S. based positions only, the pay range for this position is $136,000.00-$204,000.00 Annual. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate may be influenced by a variety of factors including skills, qualifications, experience and location. In addition, this position may also be eligible to earn performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI). GE HealthCare offers a competitive benefits package, including not but limited to medical, dental, vision, paid time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement.Additional InformationGE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunity Employer ( . Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.Relocation Assistance Provided: NoApplication Deadline: December 19, 2024