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Quality Assurance Staff Engineer

Company: CareFusion Manufacturing
Location: San Diego
Posted on: November 22, 2021

Job Description:

Job Description SummaryJob DescriptionBe part of something bigger!BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.About the Role (Summary)The Quality Assurance Staff Engineer - Investigations plays a vital role in leading investigational activities relating to infusion pumps and monitoring devices. You will be the primary resource for investigation engineers with less experience. You, and the DCHU engineering team, will work to find the root cause of customer issues, and in some instances drive corrective action for devices returned from the field. You'll determine your investigational work priorities as well as influencing the work priorities of other team member's within the department. You'll be responsible for the integrity of investigations and ensure conclusions are clear, supported, robust, and compliant. You'll create and establish best practices in investigation failure analysis processes and associated root cause determination, including inspection, test protocols and methodologies. You'll need to use strong electromechanical skills and effective communication across all levels of the company to drive to resolutions. You'll also need to apply engineering knowledge to solve standard and non-standard problems. Furthermore, you'll be accountable to ensure that MMS Infusion complaints comply with MDSAP and FDA (or primary regulations of their respective countries) through the implementation of an effective investigational process.Duties & ResponsibilitiesBe a subject matter expert for infusion products, how products are used, as well as how they are serviced.Solve complex problems by developing investigation test methodologies and processes.Lead in-depth investigations & root cause analysis efforts for Corrective & Preventive Actions (CAPAs).Lead 3rd party investigation on device failures to determine root cause.Effectively present root cause conclusions to leadership and critical customers.Design and release investigation electromechanical test fixtures.Be a lead contributor on projects that drive product safety, product quality, and customer satisfaction.Perform project management as it relates to complex investigations, releasing test fixtures or testing methodsMay coordinate all aspects of the failure investigation on new emerging issuesIdentifies and implements efficiency and compliance improvements to the complaint investigation processSupport or lead efforts to ensure customer satisfaction, as needed.Provide regular and consistent updates to leadership on complaint investigation trends and observations.Develops and implements programs to establish and maintain quality standards of existing products and service, as well as developing programs to focus employees on quality improvements.Qualifications (Education & Experience)BS in Mechanical/Electrical or Biomedical Engineering7 years' experience in Engineering role (Failure Investigation preferred)Demonstrated history of root cause determination in electro-mechanical, software-driven medical devices.Demonstrated history of CAPA ownershipSolid knowledge of FDA regulations 21CFR Part 820Solid knowledge of MDSAP and ISO 13485 StandardsExtensive experience with data analytics and Power BI platformLean Six Sigma certification a plusSpecific knowledge of infusion pump preferredKnowledge, Skills & AbilitiesDemonstrated ability to mentor/lead exempt and non-exempt level personnel within work area/departmentMust possess ability to establish new failure investigation processes, test protocols, and procedures and to build a team performing these activities.Ability to analyze complex engineering drawings from system level to component.Applies knowledge and skills to a wide range of standard and non-standard situations.Meticulous attention to detail and accuracy.Strong communication and organizational skills.Excellent writing skills, knowledgeable of good documentation practices and writing to different audiences.Ability to work on multiple projects with various disciplines, flexibility and innovation.Ability to effectively present information to management, ancillary departments, and/or customers.Flexibility and excellent organizational skills to manage/adapt to competing priorities and volume of tasks.Physical demandsWhile performing the duties of this job, the employee is occasionally required to stand or walk, stoop or kneel; is frequently required to use hands to finger, handle or feel objects; is regularly required to sit, talk, see and hear.The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close and distant vision, and the ability to adjust focus.Environmental conditionsFailure Investigation Lab and Office environment with moderate noise, little dust, temperature changes, etc. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.Employment at BD is contingent upon the Company's receipt of sufficient proof that you are or will be fully vaccinated against COVID-19. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law. Why join us?A career at BD means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our associates can fulfill their life's purpose through the work that they do every day. You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program - which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components - is designed to support the varying needs of our diverse and global associates. To learn more about BD visit Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.Primary Work LocationUSA CA - San Diego TC Bldg CAdditional LocationsWork Shift

Keywords: CareFusion Manufacturing, San Diego , Quality Assurance Staff Engineer, Engineering , San Diego, California

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