Danaher Corporation Senior Manager Quality Assurance in Miami, Florida
Danaher Company Description
Beckman Coulter develops, manufactures and markets products that simplify, automate and innovate complex biomedical testing. Our diagnostic systems, found in hospitals and other critical care settings around the world, produce information used by physicians to diagnose disease, make treatment decisions and monitor patients. Scientists use our life science research instruments to study complex biological problems including causes of disease and potential new therapies or drugs. More than 275,000 Beckman Coulter systems operate in both diagnostics and life sciences laboratories on all seven continents. For 80 years, our products have been making a difference in peoples’ lives by improving the productivity of medical professionals and scientists, supplying critical information for improving patient health and reducing the cost of care. Beckman Coulter offers a broad array of comprehensive, competitive benefit programs that add value to associates' and their families' lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits. We think you'll like what you see. If you believe your education and experience are in line with the position description and qualifications referred to above, and are motivated, energetic, and looking for a new and exciting opportunity, please submit your resume online at the URL below or atwww.beckmancoulter.com. Beckman Coulter is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, national origin, religion, gender, age, marital status, disability, veteran status, sexual orientation, gender identity, or any other characteristic protected by law.
The CAPA Manager is responsible for the management and overall effectiveness of the Corrective and Preventive Actions (CAPA) process; responsible for high level management of the CAPA process within all areas of the global Business Unit (BU) to contribute to the continuous improvement strategy that is an integral part of the Quality Management System (QMS). The CAPA Manager has a key role in assessing and managing the CAPA process and its metrics and enhancing the local and global CAPA process. Responsible for developing and managing CAPA operational processes for strategic initiatives; responsible for CAPA oversight process within and outside the QRA organization by collaborating with the Global Business Unit (Hematology, Flow Cytometry & Urinalysis).
The roles and responsibilities of CAPA Manager include but is not limited to the following:
CAPA Process. Oversight of the CAPA process; maintain continuous alignment of CAPA program scope with strategic business objectives. Communicate, collaborate and work closely with CRB (CAPA Review Board) Manager, consult frequently with cross-functional teams such as Manufacturing, Operations, Engineering, Service/Support, Sales, Research and Development, Quality, Regulatory and Marketing, in addition to other functional groups. * Develop, implement, maintain and improve Corrective and Preventive Action (CAPA) processes; Ensure the effectiveness of implemented actions and overall effectiveness of the CAPA system; Ensure that best practices are implemented and followed for problem solving, root cause analysis, solution selection tools and global impact assessments. Holistically ensure that effectiveness of CAPAs are robustly and effectively managed. * Provide oversight and direction for management all phases of CAPA to ensure compliance and timely resolution; Facilitate the identification and deployment of resources to investigate and resolve issues in a timely and effective manner; Facilitate the evaluation of CA/PA plans for appropriate resolution of root cause. * Responsible for the development of key CAPA metrics in the area of timeliness, effectiveness and root causes. * Responsible for ensuring that Business Units CAPA processes are continuously aligned with industry best practices. * Responsible for reporting quality management system data aligned with leading and lagging KPIs; Work with global business process owners to devise appropriate metrics to improve product and process; Report updates on CAPA Process to the Leadership teams and escalate awareness of events that may contribute negatively to CAPA processes or outcomes. * Establish effective and engaging training for CAPA system across organization. Ensure that individuals who are novices in CAPA are mentored and coached. Collaboration/Communication. Routinely communicate project goals, status, requirements, and deliverables to the Business Unit. Regularly interact with senior management on functional issues and make presentations to Sr. Management when required. Represent the business unit post-market quality in cross-functional projects; Perform other related duties and assignments as required. Work closely with Business Unit management to define, support, and implement functional infrastructure to support the needs of the Hematology, Cytometry and Urinalysis business.
Audits. Provide a high level of professional support during internal and external audits; Serve as a CAPA subject matter expert during audits. Ensure accuracy and completeness of pertinent records and documentation. Responsible for coordination of CAPA data analysis and data review processes for audit readiness.
Project Management. Responsible to plan, coordinate, implement and finalize CAPA related projects according to the specifications and deadlines; develop, track, maintain, and manage project plans and timelines; provide reports on project status; provide additional documentation on project as needed; identify, track, and resolve all project risks and issues; establish, modify, implement, and monitor systems and procedures to enhance timely and efficient workflow. Responsible for ensuring the completion of overall project goals in a timely manner; schedule tasks and coordinate with various team members to accomplish the results; responsible for keeping the projects on track via effective and frequent communication.
Maintain professional and technical knowledge and continually update job knowledge by interacting with “Subject Matter Experts”, reviewing professional publications, establishing and maintaining personal networks, benchmarking state-of-the-art practices, participating in educational opportunities and professional societies, reading professional publications, and participating in educational opportunities. Maintain current knowledge of global regulations impacting CAPA activities. Apply knowledge, develop processes, optimize processes, and suggest improvement to current processes as needed.
EDUCATION & CERTIFICATIONS: * Bachelor’s degree in Science and 9 years of relevant Quality/Regulatory Affairs experience or Master’s degree in Science and 7 years of relevant Quality/Regulatory Affairs experience or doctoral degree in field with 4 years or relevant experience * Certified Quality Auditor certification (Preferred) * Medical Technologist certification (Preferred) EXPERIENCE DESIRED: * Minimum of 5-9 years of relevant Quality/Regulatory Affairs experience work experience in scientific or engineering management. * Significant experience and understanding of quality assurance processes within the medical device industry with an analytical and organized approach. * Experience and ability in project management and team facilitation and leadership. * Demonstrated knowledge of BEC products (Hematology, Flow Cytometry, and Urinalysis). * FDA regulated environment experience is required. * Ability to drive results, foster teamwork, handle pressure, and provide feedback * Knowledge of domestic and international quality systems and other standards such as FDA QSR, MDD, CMDCAS, SFDA, JPAL, ISO 13485, ISO 14971, World Health Organization or other applicable standards and regulations. * Experience participating on cross functional teams. PERSONAL SKILLS / ATTRIBUTES: * Able to work effectively in a collaborative team environment, across multiple functions. Able to skillfully manage conflict and bring issues to timely resolution. * Excellent communication and interpersonal skills. Strong leadership and multitasking abilities. Possess a unique blend of business and technical savvy, a big picture vision and excellent understanding of CAPA and QS activities. * Able to apply business understanding and technical expertise and full knowledge of other related disciplines to assist in solving complex technical and business issues; Able to make judgment calls using combination of knowledge of regulations, knowledge of technology, critical thinking, and interpretation of intent of the regulations. * Readily accepts responsibility and accountability for project success and key decisions. * Proven ability to work cross-functionally in a team based environment. * Proficient in MS Office Suite of products. * Willingness to be flexible and adaptable to changing priorities. * Excellent oral and written communication skills. * Effective analytical and problem solving skills.
Diversity & Inclusion At Danaher, we are dedicated to building and sustaining a truly diverse and inclusive culture. These are not just words on a page—Diversity and Inclusion is a top priority for the company, and it ties deeply to each of our core values. Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.
Danaher Corporation Overview
Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 71,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $19.9B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 5,200% over 25 years. At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We're innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you'll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team. Danaher is committed to competitive compensation that typically has key components including base salary, variable annual incentive compensation based on personal and company performance, and long-term incentive.
Organization: Beckman Coulter - Diagnostics
Job Function: Quality and Regulatory Affairs
Primary Location: North America-North America-United States-FL-Miami
Req ID: BEC015198