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Danaher Corporation Quality Assurance Manager in Vista, California

Leica Biosystems’ mission of “Advancing Cancer Diagnostics, Improving Lives” is at the heart of our corporate culture. We’re a global leader in cancer diagnostics with the most comprehensive portfolio from biopsy to diagnosis. Our easy-to-use and consistently reliable offerings help improve workflow efficiency and diagnostic confidence.

Our associates know that every moment matters when it comes to cancer diagnostics. When you come to work, you’re helping develop solutions that enable accurate diagnoses to turn anxiety into answers. Join our diverse, global team of talented people, and be inspired to grow every day.

Leica Biosystems is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, we’re working at the pace of change to improve patient lives with diagnostic tools that address the world’s biggest health challenges.

The primary role of the Quality Assurance Manager is to provide leadership and support of daily quality operations including complaint handling, CAPA, document control, training, inspection and product release activities. This position ensures that the business, product and processes meet all Quality and Regulatory standards and requirements. The Quality Assurance Manager will also be responsible for supporting the implementation and maintenance of an electronic Enterprise Quality Management System.

Major Responsibilities

  • Hire, develop, engage and retain highly capable QA team ensuring that each associate is meeting performance requirements and that each critical position has an identified successor with a targeted and robust development plan.

  • Oversee complaint handling and resolution, CAPA, document control, training, inspection and product release activities.

  • Increase associate engagement year-over-year by analyzing survey data, going to GEMBA with associates and developing and implementing robust and effective engagement plans.

  • Ensure that cross-functional teams and projects are staffed with qualified and skilled QA -associates who are ready users of Daily Management and who are strong and credible representatives of their discipline. When resource constraints exist, notify stakeholders and recommend countermeasures to ensure business needs are met.

  • Participate in Daily Management meetings and communicate to Leadership team effectively and timely on issues, risks and needs.

  • Plan, prioritize and coordinate workflow and cross-site/function interactions to ensure on time delivery of product and projects and compliance with quality systems /standards.

  • Ensure site audit readiness at all times through monitoring and learning from past audits, training and preparation of staff and mitigation of risks.

Required Education, Experience, Skills

  • Bachelor's degree or equivalent advanced degree in engineering, science, medical, or technical field and 5+ years' experience with increasing responsibility in medical device/IVD

  • Experience working within a medical device quality system in compliance with US FDA, ISO 13485 and EU MDR/IVDR regulations

  • Experience, within the last 5 years, in implementing a full eQMS software solution at site level with global interconnections

  • Experience leading teams of professionals in setting and achieving corporate and business objectives.

  • Proven experience in developing and implementing mining tools to monitor product complaint trends including defined control and/or action limits to detect emerging field issues

  • Track record of collaborating with technical groups to identify product improvement opportunities

  • Proven experience in providing strategic direction and leadership for CAPA Process resulting in successfully supporting the effective implementation, maintenance and improvement of the CAPA process including global solutions with business partners and across sites

  • Recent experience with quality impact of China regulation updates and proven experience of manufacturing requirements to meet China standards (strongly preferred)

Travel: Minimal <5

This job description in no way states or implies that these are the only duties to be performed by this employee. The incumbent is expected to perform other duties necessary for the effective operation of the depart

When you join us, you’ll also be joining Danaher’s global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.

Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.The EEO posters are available here (https://www.dol.gov/agencies/ofccp/posters) .We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at applyassistance@danaher.com to request accommodation. If you’ve ever wondered what’s within you, there’s no better time to find out.