Quality Engineer II - Instrument Plant

Becton Dickinson Medical Devices•Sparks, NV

13d•Onsite

About The Position

As a Quality Engineer II, you will be the go-to expert for applying and interpreting plant and department procedures, ensuring consistency and compliance with Quality Systems. You will leverage sophisticated statistical and analytical tools while working across enterprise systems and corporate directives to support both new and existing product lines. This role is with Waters Corporation, a global leader in life sciences dedicated to accelerating the benefits of pioneering science through analytical technologies, informatics, and service. Waters focuses on regulated, high-volume testing environments and collaborates with analytical laboratories worldwide to advance the release of effective, high-quality medicines, assure the safety of food and water, and drive better patient outcomes. The company has a passionate team of approximately 16,000 colleagues.

Requirements

Bachelor's degree. Typical degrees in Biological Sciences, Chemistry, and/or Regulatory Affairs.
2+ years’ experience in Quality Assurance, Quality Control, or Product/Process non-conformance investigations.
Experience in a medical device or pharmaceutical manufacturing facility.
SAP transaction experience.
Multi-task management and change management plan execution.
Conflict management and results-driven performance with minimal supervision.
Team collaboration and cross-functional coordination.
FDA 21 CFR 820 regulations (moderate knowledge).
ISO 9000:2000 and ISO 13485:2003 standards (moderate knowledge).
GLP/GMP/ISO requirements and Quality System regulations.
Medical device regulations and regulated environment experience.
Design Control requirements.
Data analysis using Six Sigma, root cause analysis, failure analysis, and risk assessment (moderate to difficult complexity).
Statistical methods and tools application.
Risk management and risk-based decision making.
Proficiency in Excel, PowerPoint, and statistical software packages.
Word processing and spreadsheet expertise.
First-hand audit experience (Preferred).

Nice To Haves

Medical Device Validations (preferred).
Microbiology/molecular science background (Preferred).
Data efficiency optimization (Preferred).
Manual assembly manufacturing experience.
Microbiological and chemical test methods.

Responsibilities

Champion Quality Compliance: Maintain International Organization for Standardization (ISO) and regional regulatory requirements across the entire product lifecycle - from design and manufacturing to assembly, testing, inspections, and customer complaint resolution.
Master Documentation: Develop and maintain Device History Files in full compliance with regulatory requirements, ensuring every detail is captured and accessible.
Drive Quality Intelligence: Generate critical CTQ (Critical to Quality) indices and provide actionable recommendations and solutions to emerging issues for project teams, operations, and suppliers.
Lead Product Integration: Support the seamless integration of new products into Manufacturing and Operations, ensuring quality is built in from day one.
Ensure Regulatory Excellence: Guarantee that BD Diagnostic Systems divisional and departmental policies, procedures, practices, and facilities meet all applicable regulatory requirements.
Mentor and Coach: Share expertise by helping others understand and apply Quality Systems and procedures effectively.
Analyze and Optimize: Perform sophisticated trend analysis, risk management (including FMEA, Hazard Analysis, and Fault Tree analysis), and apply Six Sigma tools to drive continuous improvement.
Variety: Support one or more instrument platforms on sustaining activities including complaints, non-conformances, and daily operational challenges.
Leadership Opportunities: Take the lead on root cause investigations for moderately complex issues and make a tangible difference.
Cross-Functional Collaboration: Work closely with Research and Development, Operations, and other key departments.
Hands-On Problem Solving: Actively participate on teams, support audits, ensure documentation compliance, and process CAPAs, change controls, and deviation waivers.
Strategic Impact: Your work directly influences product quality and customer satisfaction across our entire portfolio.