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SCIEX · 5 months ago

Lead Principal Specialist, Quality Assurance and Regulatory Compliance Service

Richmond, Illinois, United States

Full-time

Onsite

Senior Level, Lead/Staff

$120K/yr - $130K/yr

7+ years exp

Leica Biosystems, a part of Danaher Corporation, is dedicated to advancing cancer diagnostics and improving lives through innovative solutions. The Lead Principal Specialist, Quality Assurance and Regulatory Compliance Service will provide leadership and support in maintaining compliance with quality standards and regulations across global operations, while also managing quality activities at the Richmond service and repair shop.

BiotechnologyManufacturingMedical DeviceProduct Design

H1B Sponsor Likely

Responsibilities

Establish and maintain Quality requirements at the LBS SUs Globally including training (example: complaint handling, adverse event escalation, recall, product classification, and product claims), execution of field action activities, and ensuring compliance of the Service and Installation records

Establish and maintain Quality requirements at the Richmond SU Service and Repair shop including proper processing of the medical devices, and training to the QMS procedures

Lead as the core representative for internal and external audits of both the SU QMS and the Richmond SU Service and Repair Shop

Serve as Project Manager for designated improvement projects

Effectively use Danaher Business System (DBS) tools to drive continuous improvement

Qualification

Medical device quality systemsQuality Management certificationsContinuous improvement toolsProject ManagementExceptional communication skills’s degree in scienceProblem-solving skillsRelationship building

Required

Bachelor's degree in science, medical or technical field required

7+ years' work experience with increasing responsibility in medical device/IVD Quality Assurance showing extensive knowledge of medical device quality systems including but not limited to 21 CFR 820, MDSAP, ISO 14971 and ISO 13485 required

Experience with problem-solving and continuous improvement tools required

Specific experience in driving compliance of quality systems required

Exceptional communication skills (verbal/written/presentation/relationship building) with ability to work collaboratively with customers, cross-functional project teams and regulators required

Preferred

Certifications preferred: Quality Management, Quality Auditor, Lead Auditor, Six-Sigma Black Belt, Quality Engineer

Benefits

Paid time off

Medical/dental/vision insurance

Retirement Benefits

Company

SCIEX

Glassdoor3.3

SCIEX is a biotechnology company that sells mass spectrometers, capillary electrophoresis, and ion sources products.

Founded in 1970

Framingham, Massachusetts, USA

1001-5000 employees

http://www.sciex.com

H1B Sponsorship

SCIEX has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (1)