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Danaher Corporation Design Assurance Quality Manager in Vista, California

Leica Biosystems 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. Learn more about Leica at www.leicabiosystems.com.

The Design Assurance Manager provides quality engineering and design control support for integrated software and hardware development projects and develops and leads a team of quality engineers. This role will oversee multiple project deliverables, as well as, provide review and guidance for risk management, verification and validation activities related to the development projects. The Design Assurance Manager also provides expertise on design and development of software products and quality processes including agile, SaaMD, AI/ML, and Interoperability.

Responsibilities we will trust you with:

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

  • Participate in cross-functional teams at various phases of the development cycle as the Quality Engineering representative. Work independently and with project team members to develop design control deliverables including quality plans, design controls deliverables, test methods, and Design History Files.

  • Provide direction to development teams in State of the Art (SOTA) methods and processes for the design, verification and validation of hardware, SaaMD and AI/ML software products.

  • Work closely with Regulatory Affairs on deliverables for global regulatory submissions, including FDA pre-submissions, 510k and IVDR CE certifications.

  • Participate in the development and maintenance of product risk management, hazard analysis and FMEAs in accordance with ISO 14971.

  • Work independently and with project team members to develop and improve product and processes to reduce variability and increase robustness throughout the development cycle for multiple projects.

  • Prepare regular performance reports for Quality Management Systems and project development. Maintain associated databases and design reports to reflect management input and changing organizational needs.

  • Ensure compliance of the design control processes to meet current and state of the art quality and regulatory requirements.

  • Provide quality subject matter expertise and support during internal and external audits for the design processes and design history files.

  • Meet company and departmental goals in the continuous improvement of all products, services and processes.

  • Ensure that cross-functional teams and projects are staffed with qualified and skilled associates who are effective users of Daily Management and who are strong and credible representatives of their discipline.

Your areas of knowledge and expertise that matter most for this role:

  • BS/BA in Engineering or a technical field preferred

  • Min 8 years experience in quality field in a medical device, IVD or similarly regulated industry required

  • Working knowledge of design controls for Class II (510k) and Class IIb (MDR) or Class C (IVDR) products required

  • Prior management experience or demonstration of leadership skills required

  • Experience with software and software/hardware development including strong working knowledge of 62304, SaMD, Agile methodologies, 14971 Risk Management, Cybersecurity & Interoperability required

  • Experience with AI/ML or Digital Health preferred.

Check out our benefits here: https://danaherbenefitsinfo.com/

All employment offers are contingent upon successful completion of our pre-employment drug screening and background/criminal check.

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.

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 department or unit. This job description may be changed at any time.

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Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified 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. The “EEO is the Law” poster is available here (http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf) .

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