1. Adheres to Integer Values and all safety and quality requirements including, but not limited to: Quality
Management Systems (QMS), Environmental Management Systems (EMS), U.S. Food and Drug Administration (FDA) regulations, Company policies and operating procedures, and other regulatory requirements.
2. As a quality Core Team member, actively participates in development project teams. Performs quality/reliability engineering activities to ensure that the design/development procedures, design controls, supplier controls and test requirements are fulfilled. Builds consensus where appropriate.
3. Leads Risk Management (ISO 14971) activities. May leads cross functional teams in planning, analyses (DFMEA, FTA, Risk/Benefit) and mitigations. Maintains risk management file for the life of the device.
4. Generates and/or reviews related project deliverables such as: design verification and design validation protocols and reports as well as process validation protocols and reports. Coordinates with R&D in the review of technical documentation.
5. Works with Product Development Manufacturing Engineering in the development of test fixtures, develop production acceptance criteria and test methodology.
6. Coordinates sourced item qualification activities and supports supplier risk management initiatives. Conducts Independent review of DHF and Technical files, provides technical standards interpretation, and determines appropriate statistical methods, including sample size determination.
7. Provides support in conducting root cause analyses, preparation of CAPA and Distributed Product Risk Assessment. Draft and update SOPs as required.
8. Performs other functions as required.
Job Requirements Minimum Education:
Bachelor's Degree in Engineering or related field required. Master's Degree preferred.
5-7 years of experience.
Practical knowledge of FDA Quality System Regulations, ISO 13485 and Medical Device Directive.
Practical knowledge of ISO 14971, and related standards
General familiarity with industry best practices in development, testing and manufacturing processes.
Experience in interpreting design schematics and drawings.
Preferred experience with FDA and European regulated medical devices
Skilled in statistical methods e.g. ANOVA, SPC, test sample size selection plans, Gauge R&R, and DOE.
Demonstrated proficiency utilizing quality lean sigma tools (e.g. Root Cause Analysis, QFD, Ishikawa, Kepner-Tregoe).
Experience in establishing and implementing quality metrics for product development.
Strong collaboration, negotiation, and conflict resolution skills.
Excellent verbal and written communication skills..
Excellent technical writing.