Quality Engineering

Job Summary

The Staff Quality Engineer works with cross-functional teams with the goal of ensuring and maintaining product safety and efficacy. The position uses technical knowledge and experience to ensure strategies for product and processes meet regulatory and business objectives. This role advises management on systems and techniques to maintain efficient and compliant systems.

Key Accountabilities

• Teamwork: Is Quality Engineering lead on design and development projects, product and process changes, risk management, root cause investigations, validations, process capability, and trend analysis. Provides team with strategic and tactical guidance related to Quality Management procedures for design and development, production, and post-production (post market) activities. Drives improvement projects and initiatives that reduce systemic manufacturing defects; improve quality systems. Independently lead multiple long-term projects.
  
  Interact with supervisor as required on activities, issues, or turning points. Models effective team dynamics behavior. Encourages and empowers others to achieve project outcomes. Provide training and guidance to junior members of the team.
• Product and Process Life Cycle: Represent Quality Engineering in Design and Development activities through launch, Product and Process Changes, sustaining On-Market safety and efficacy, and Post-Market Surveillance endeavors. Provide Quality-consensed subject matter expertise and ensure the delivery of objective evidence using scientific methodology which is technical validity, accuracy, complete, and comply to applicable regulations and standards in QMS areas such as product and process development, specification development, acceptance methods development, design transfer, design validation, process validation, risk management, product realization, packaging and shipping validation, product launch, and nonconformance assessment.
• Risk Management: Acquire and maintain current knowledge of applicable requirements for risk management activities and produce audit ready Risk File documents in compliance with the requirements of current international risk management standards and regulations. Coordinate evaluation of new and emerging risk standards Assist in the development of plans for meeting and complying with new risk regulations, guidances, and standards.
• Quality Science and Engineering: Perform independent quality review and evaluation of change orders including related data for scientific approach, presence of supporting objective evidence, technical validity, accuracy, completeness, and compliance to applicable regulations and standards. Provide guidance on identified gaps and collaborates to determine remediation activities. Apply critical analytical thinking in the investigation process specifically during root cause analysis, risk assessment evaluation and determination corrective and preventive actions determination to guarantee gaps are properly addressed.
  
  Provide consensed Quality input into process investigations using a systematic approach to ensure root causes and CAPAs are aligned. Collect and analyze defined quality metrics, quality-related data to identify issues or trends.
• Quality Engineering Strategic and Tactical Management. Assist Quality Engineering management with development of strategic and tactical options for accomplishing company goals and initiatives. Implement assigned strategies and tactics. Manage Quality Engineering consultants when engaged to assist with goals.
• Quality Management Systems: Identify applicable processes for new standards and regulations. Ensure departmental records, QMS procedures, and controlled documents comply with applicable regulations and standards. Aid in designing and documenting new and revised quality systems for product realization compliance with applicable regulations and standards. Ensure QMS processes, procedures, and quality documentation to maintain a state of audit readiness. Escalate events that may contribute negatively to medical devices safety or efficacy.
  
  Address and remediate events that may contribute negatively to QMS processes or effectiveness. Apply critical analytical thinking in the investigations and nonconformance systems specifically during root cause analysis, risk assessment evaluation, and corrective and preventive actions determination to guarantee that (potential and actual) nonconformances are properly addressed. Support other functions in resolving on quality systems issues and concerns.
• Audit: Support internal, and third-party audits, regulatory inspection preparation and execution. Assist in closing audit findings by providing quality guidance for investigations, and implementation of resulting corrections, and/or corrective actions/preventative actions.
• Ensure compliance with applicable Inova standard operating procedures (SOPs), ISO, FDA and other Quality System regulations, as well as applicable Environmental Health & Safety, Human…