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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.

Position Summary: The Senior Engineer, Quality Assurance and Regulatory Compliance for Leica Biosystems is responsible for providing Quality Engineering support for end-to-end manufacturing and sustaining hardware and software projects.

This position is part of the Quality Assurance and Regulatory Compliance department located in Vista, California and will be on-site. At Leica Biosystems, our vision is to advance cancer diagnostics and improve lives.

You will be a part of the Quality Assurance and Regulatory Compliance team and report to the Director, Quality Assurance and Regulatory Compliance, responsible for completing specific project deliverables and supporting change management, Design History File (DHF), risk management, and Design and Process verification and validation activities related to the product sustainment projects. If you thrive in a collaborative, fast paced, multifunctional, continuous improvement role and want to work to build a world-class manufacturing organization — read on.

In this role, you will have the importunity to:

• Work independently and with cross-functional project team members to develop process and design deliverables including quality plans, manufacturing and inspection documentation, test methods, and Device History Records and assist with the development of project verification and validation activities.

• Support Nonconforming Material process (NCMR) including investigation, analysis, root cause identification, and chair material review board, including trending of NCMRs.

• Assist in troubleshooting and root cause analysis for issues faced during execution of process verifications, validations, and Design Transfer to manufacturing in accordance with established procedures and transfer schedules.

• Develop and implement test and inspection processes for Incoming Materials, Work In-Process, and Finished Devices, including all necessary validation and qualification activities.

• Assist in the performance and documentation of internal and external audits in accordance with internal and supplier auditing schedules and respond to audit findings by proposing and implementing necessary corrective actions both at the supplier and internally.

The essential requirements of the job include:

• BS/BA in Engineering or a technical field

• 3+ years’ experience in quality field in a medical device or similarly regulated industry or 5+ years’ experience in manufacturing or production environment

• Experience with manufacturing within a regulated industry including strong working knowledge of ISO 13485, ISO 14971 and 21 CFR 820

• Ability to effectively communicate (verbal and written) information in English (Ability to communicate in Spanish is a plus)

Travel, Motor Vehicle Record & Physical/Environment Requirements:

• Ability to travel up to 15% of the time (domestic)

• Ability to lift, move, or carry equipment up to 20 lbs

It would be a plus if you also possess previous experience in:

• Effective presentation/communication skills and project/resource management skills

• Ability to work independently and in a team environment, including with management and technical staff

• Demonstrated skills in problem solving, root cause analysis, and implementing corrective and preventive actions to prevent recurrence.

Compensation:

The salary range for this role is $120,000 - $125,000. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. We may ultimately pay more or less than the posted range. This range may be modified in the future.

This job is also eligible for bonus/incentive pay.

We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance, and 401(k) to eligible employees.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law.

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At Danaher we bring together science, technology and operational capabilities to accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. Our global teams are pioneering what’s next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit www.danaher.com.

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.