Responsibilities:

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  Develop and implement reliability analysis, design, validation and assessment methods to support successful new product introductions and or sustaining product changes
• Provide quality leadership to new product development teams in the areas of design control, design verification and validation, design transfer, process validation, risk management, and specification development.
• Drive product risk management activities and ensure quality and completeness of project design history files, validation packages, and change orders
• Provide ongoing quality engineering support throughout the product life cycle. Provide support to development, engineering and manufacturing functions for validation planning and transfer activities. Assist teams in determining validation needs strategies and requirements. Ensure product development and validation programs meet requirements of FDA and ISO when applicable
• Lead in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements
• Manages Quality Notifications (QN) for non-conforming product and deviations. Monitors Quality Notification progress and works with cross-functional team to complete QN per requirements.
• Set Reliability goals for products and their subsystems in the field and measure against progress. Maintain a knowledge base of lessons learned to enable continuous improvement
• Oversee QC Inspectors and ensure adherence to procedures
• Provide management with status updates on assigned responsibilities and goals and escalate issues in a timely fashion
• Writes detailed Risk Assessments, updates Process Hazard Analysis, and present analysis to the Risk Management Board
• Trend, analyze, and report on quality data in order to improve product and process; develop recommendations based on data analysis

Qualifications:

• Bachelor’s degree in Mechanical, Electrical, Reliability Engineering, or related.
• Minimum 4+ years’ experience in quality assurance field in a regulated environment
• Minimum 4+ years’ experience in medical device industry
• Quality Certification preferred (e.g., CQE)
• Knowledge of medical device regulations (FDA 21CFR80.820, ISO13485, ISO14971)
• Results orientation with strong written and oral communications skills to lead cross-functional teams.