Beckman Coulter develops, manufactures and markets products that simplify, automate and innovate complex biomedical testing. Our diagnostic systems are found in hospitals and other critical care settings around the world and 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. Hospital laboratories are our core clinical diagnostic customers. Our life science customers include pharmaceutical and biotechnology companies, universities, medical schools and research institutions. More than 275,000 Beckman Coulter systems operate in both diagnostics and life sciences laboratories on six continents. For more than 75 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.
Reporting to the CAPA (Corrective and Preventative Actions) Manager, as Quality Assurance Engineer / Six Sigma Black Belt, you will be responsible for ensuring that all CAPA stages, particularly Failure Investigation (FI), utilize appropriate statistical and/or FI tools
you will also independently plan, coordinate, and report on product quality programs, which provide a basis for sound technical decisions using techniques in experiment design and data analysis. This is much more than a failure investigations or QA role -- you will be involved in a variety of high impact activities including corrective actions, effectiveness checks, setting up design experiments, and more.
Serving as an integral member of the CAPA Review Board, you will work to directly support approximately 100 of the company's 250 CAPA owners to ensure that CAPA activities are performed systematically, according to plan and are well documented. While also acting as this key resource to CAPA teams, you'll provide guidance in the selection and use of statistical and FI tools as well as ensuring teams are heading in the correct direction early in the process. Your days will be varied, and you can expect to assist CAPA owners with a variety of projects, from helping to justify a sample size to assisting in writing an effectiveness check criteria.
You will also be involved with the development and deployment of training materials related to FI activities within the CAPA process. Over time, we'll expect you to be the recognized expert in the tools related to FI. Additionally, you will also ensure the proper makeup of investigation teams and that the CAPA teams are resourced for success and that resources are available as required. Working to ensure investigations are progressing in a timely manner according to prioritization and investigation, running metrics and reviewing high priority CAPAs will be additional central components to your role.
Your key knowledge systems and areas of expertise should include:
A solid understanding of the CAPA process, the interactions between the CAPA process, and the other areas of the Quality Management System (Complaints, Recalls, Nonconforming product, Medical Device Reporting/Vigilance, Risk Management, Design Control, etc.)
Expertise in FI, statistical and data analysis tools and when to appropriately utilize them.
Ensuring that investigation plans for CAPAs are carried out with a balance to speed and thoroughness.
The ability to deliver FI training in a class-room style setting and to train teams on appropriate tools for investigation, root cause identification and selection of Corrective/Preventive Actions.
To excel in this role, you will need to leverage your extensive statistical knowledge to serve as a mentor and coach to the CAPA owners who you will be working with on a daily basis. You'll enjoy the satisfaction of overcoming the inherent challenges that come with influencing and mentoring your team members on the proper selection and utilization of tools. You will need to be an outstanding influencer, and have the ability to convince people that a specific tool is the right one to use with the proper justification.
Additionally, in order to be an outstanding Staff Quality Assurance Engineer / Six Sigma Black Belt, you'll need to know how to ask the right questions. Our CAPA owners will be turning to you for assistance, so you'll need to tailor your interactions in a way that uncover the variables and desired outcomes. Approachability coupled with knowledge will be essential. You will help to plan, analyze and conclude each test or investigation you assist with.
The ability to systematically gather relevant information; consider a broad range of issues or factors and grasp complexities and recognizes relationships.
To be a good fit for this opportunity you will have:
A relevant baccalaureate college degree, in engineering.
5+ years of experience in a field investigation or quality engineer role
Six Sigma Black Belt certification with at least 2 years of applied, hands-on Six Sigma experience.
Very strong experience with statistical tools.
Strong skill with computers, including proficiency with Microsoft Office (Word, Excel, PowerPoint, etc.), and familiarity with statistical software such as Minitab.
The ability to function as a team player and effectively operate in and facilitate cross-functional teams.
Excellent multi-tasking skills, including the ability to plan and execute multiple projects simultaneously.
Strong verbal and written communication skills, including documentation skills.
The ability to effectively communicate with all levels of the organization from operations to executive management and with external customers.
Medical industry experience is preferred.
Depending on your performance and future business needs, you may have the opportunity to travel internationally as you evolve in the role.
Danaher is a diversified technology leader that designs, manufactures, and markets innovative products and services to professional, medical, industrial, and commercial customers. Our portfolio of premier brands is among the most highly recognized in each of the markets we serve. Danaher's portfolio is comprised of five reporting segments: Test & Measurement; Environmental; Life Sciences & Diagnostics; Dental; and Industrial Technologies. Driven by a foundation provided by the Danaher Business System, Danaher's 48,000 associates serve customers in more than 125 countries and generated $13.2 billion of revenue in 2010.
North America-United States-CA-Brea
Danaher - 2 years ago