BD (Tissuemed Ltd) · 2 months ago
Lab Service Quality Engineer
Temecula, CA
Full-time
Onsite
Senior Level
$81K/yr - $133K/yr
5+ years expBD (Tissuemed Ltd) is one of the largest global medical technology companies in the world, committed to advancing health through innovative solutions. The Lab Services Quality Engineer is responsible for ensuring quality by design and compliance with laboratory standards, leading design verification testing activities, and collaborating with cross-functional teams to support project execution.
Health CareHospitalMedicalMedical Device
Responsibilities
Lead and implement design verification testing activities for combination products in accordance with FDA 21 CFR part 210,211, 820, ISO/IEC 17025 and ISO 13485
Develop and review test protocols, methods, and reports to ensure compliance with design control and risk management requirements
Collaborate with cross-functional teams including technology development, operations and business development to support flawless project execution and delivery management
Ensure laboratory compliance with Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP)
Support root cause investigations, CAPA, OOS/OOT and non-conformance resolution related to design verification testing
Provide technical guidance and mentorship to junior engineers and laboratory staff
Participate in internal and external audits, including regulatory inspections
Maintain and improve quality systems, including CAPA, Nonconformances, calibration and maintenance and equipment qualification
Stay ahead of evolving regulatory expectations for combination products and contribute to continuous improvement initiatives
Conduct timely reviews of project documentation including but not limited to protocol, laboratory data, audit trails, and reports prior to release to the client
Provide problem solving and root cause analysis expertise to lead / support OOS/Deviation/CAPA investigations
Review Test Method Validation and provide quality expertise in the development of test methods and protocols
Act as technical QA representative during audits
Identify and drive implementation of improvements in current quality systems and processes
Achieves Key Performance Indicator (KPI) objectives by helping develop the appropriate production/quality data collection process, collecting data (including nonconformance, OOS, OOT, CAPAs, Deviations), and conducting the appropriate trending analysis to allow for the appropriate continuous improvement strategic plans to be enacted
Prepare and present quality reports and metrics to senior management
Support ZebraSci QMS integration into BD Quality Global procedures and systems
Train and guide staff in quality procedures and compliance
Qualification
Required
Bachelor's or master's degree in engineering, Biomedical Sciences, or related field
Minimum 5 of experience in quality engineering, preferably in a combination product or medical device environment
Strong knowledge of design control, risk management (ISO 14971), and verification/validation principles
Experience with mechanical and analytical testing of drug-device combination products
Familiarity with 21 CFR Part 820, 21 CFR Part 4, and ISO 13485
Excellent analytical, organizational, and communication skills
Proficiency in statistical analysis tools and quality engineering methodologies (e.g., Gage R&R, DOE, FMEA)
Preferred
Experience with Laboratory Information Management Systems (LIMS) a plus
Experience managing or participating in audits a plus
Benefits
Valuable, competitive package of compensation and benefits programs
Rewards and recognition opportunities that promote a performance-based culture
Company
BD (Tissuemed Ltd)
Experts in bioadhesives: Tissuemed develops and markets adhesive films to prevent air, blood and fluid leaks encountered in surgery.
11-50 employees
Funding
Current Stage
Early StageTotal Funding
$0.05M2021-12-09Acquired
2015-06-01Grant· $0.05M
Recent News
2025-02-21
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