Senior Quality Engineer

The Senior Quality Engineer for Leica Biosystems is responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within new product development, manufacturing, or servicing support. In this role, the Senior Quality Engineer is accountable for medical device Complaint Handling and Adverse Event Reporting processes.

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

You will be a part of the Quality Assurance team and report to the Senior Manager of QARC responsible for site quality and regulatory compliance. 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 opportunity to:

• 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 process and design deliverables including quality plans, manufacturing and inspection documentation, test methods, and Device History Records. Assist with the development of project verification and validation activities.

• Ensure accurate and timely completion of complaint failure investigations (CIRV), risk analysis, CAPA activities, and other complaint-related tasks, such as trend analysis of complaint data.

• Manage the Nonconforming Material process (NCMR) including investigation, analysis, root cause identification, and chair material review board. This will include trending of NCMRs, and determination of Corrective and Preventive Actions.

• 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. 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 with 5+ years' experience in manufacturing or production environment.

• Experience with complaint investigations and data trend analysis.

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

• Ability to identify manufacturing and development constraints. Working with management and technical staff in performing root cause failure analysis and implementing corrective and preventive actions to prevent recurrence.

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

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

• Ability to work independently and in a team environment.

• Demonstrated problem solving and root cause analysis skills.

Travel: Less than 15%.

This is on site position at Vista, CA.

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.

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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.