Senior Quality Assurance and Regulatory Compliance Engineer

3 days ago

Vista, California, United States Danaher Corporation Full time
Job 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.

About the Role

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.

This role requires a collaborative, fast-paced, multifunctional, and continuous improvement environment, with a focus on building a world-class manufacturing organization.

Key Responsibilities
  • 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.
  • 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.
Requirements
  • 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.
What We Offer

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

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