Engineer II, Quality

Position Summary

Works in a Quality Systems environment to ensure that the servicing of infusion pumps and other serialized medical devices meets the requirements of ISO 13485:2016, 21 CFR Part 820, and other applicable regulations and standards.

This position also supports key areas to maintain an effective Quality System, such as: quality operations, complaint investigations, CAPA investigation, risk management, internal audit, and service data collection, analysis, and trending. The incumbent must be a quality

professional that can work and develop within a quality management system and has sufficient skills, experience and competencies to perform in a very dynamic role within a regulated environment.

Essential Duties & Responsibilities

• Support and provide Quality oversight to the Hub Service/Repair Operations and/or Field Service Engineering organizations and Warehouse team in their daily activities.
• Maintain documentation and records resulting from quality management system activities according to established procedures.
• Perform customer complaint analyses for unreturned serialized devices.
• Process Quality holds.
• Initiate and complete Quality Investigations to identify root cause and implement effective solutions (corrective and preventive actions) for product/process quality issues, corporate/external audit observations, and quality system compliance issues as required.
• Utilize technical background (including statistical knowledge and root cause analysis tools) to assist in data collection, analysis, and reporting. This activity may relate to process improvement efforts as well as serve as an input to management for decision making.
• Actively participates in preventive/proactive quality and operations improvement projects.
• Provide inputs to the Global Service Quality Management Review and monthly Operational Review meetings.
• Support Quality Management on site readiness activities associated with external audits and regulatory inspections (can be asked to present and defend in the front room regarding complaint analysis and other Service QMS topics).
• Contribute to oversight of site regulatory compliance, including follow-up to regulatory commitments.
• Oversee and drive improvements to meet established quality objectives and performance indicator goals associated with tasks under responsibility.
• May support validation processes and risk assessments as required.
• Provide support to initiate and process Change Request packages for Quality System procedure changes.
• May lead or coordinate remediation plans associated with Quality System compliance issues.
• Ensure fulfillment of compliance training requirements per established schedule.
• May conduct internal audits per established internal audit schedule and as designated by Quality Management.
• Perform other related duties as assigned or required.
• Work on special projects as they arise.

Knowledge, Skills & Qualifications

• 2 years hands-on experience working in a regulated industry; medical device experience preferred
• Superior technical writing and problem solving skills
• Superior written and verbal communication skills, capable of synthesizing a problem statement, situation, or observation and providing a concise synopsis to upper management
• Ability to work and multi-task in a fast-paced environment
• Must be capable of organizing data from multiple sources, extracting key information, and writing technical reports with executive summaries including statistical analysis of data
• Combined education plus work experience in a medical device industry will effectively align incumbent with his/her ability to contribute to the organization
• Demonstrated knowledge of medical device regulations and experience with FDA regulatory standards and ISO 13485 strongly preferred
• Working knowledge of basic statistical techniques
• Advanced knowledge and experience in root cause analysis (RCCA) and problem-solving techniques
• Intermediate working knowledge of Excel (pivot table, filtering, graphing), Word, and PowerPoint

Education and Experience

• Must be at least 18 years of age
• Bachelor’s degree from an accredited college or university (STEM discipline)
• 2-4 years experience
• ASQ CQE / CQA certification is preferred
• ISO 13485 Lead Auditor certification a plus

Physical Requirements and Work Environment

• This is largely a sedentary role.
• This job operates in a professional office environment and routinely uses standard office equipment.
• Typically requires travel less than 5% of the time