Quality Engineer, Medical Device

Job Summary

The Quality Engineer, Medical Device is responsible for maintaining the quality system, and for developing innovative solutions to quality related problems. This role assures compliance to quality control guidelines and procedures to ensure incoming materials and finished goods comply with specifications. Assists in the design and implementation of policies and procedures for testing and evaluating the precision and accuracy of products and/or equipment.

This role assists in Root Cause Analysis/Corrective Actions, and ensures projects are completed on time and within budget. This role supports the quality assurance team regarding projects, tasks, and operations.

Reporting to: Associate Director, Quality Assurance

Location: Johnson City, TN - onsite

• Support company goals and objectives, policies and procedures, in compliance with quality systems, FDA regulations, and all other external regulatory requirements for which product is distributed.
• Assess, provide recommendations, and lead implementation of systems, processes and equipment for improvement and compliance to cGMP and ISO 13485:2016 within the Operations, Quality, and Regulatory processes. Provide written reports and supporting documentation for recommendations.
• Provide quality engineering support to manufacturing/kitting, along with support for new product launch and/or transfer.
• Develop and implement quality control process sampling systems (skip-lot), procedures, and statistical techniques.
• Perform statistical analysis of data and write technical reports.
• Ensure accurate project schedules are maintained and communicated.
• Support other quality functions, which may include QA/QC sampling plans, supplier development, and quality training initiatives.
• Present data analysis and trend information to management and other groups as required.
• Responsible for the corrective action report process (CAPA).
• Manage and track the corrective action reports to ensure action(s) are taken in a timely manner.
• Review and investigate customer complaints received per MDR's, FDA, and ISO requirements.
• Investigate reported product problems and complaint activity trends related to supplier quality.
• Review customer complaint investigations and trend analysis to identify corrective action opportunities.
• Ensure Nonconformance process is followed per procedure and provide technical input; identify and develop solutions to recurring issues, along with communication to nonconformance team.
• Support internal/external/corporate audits.
• Evaluate data and identify trends related to Nonconformance/Quality Holds, as needed; collaborate to develop innovative solutions and communicate to management.
• Lead problem-solving efforts to identify and resolve recurring and new quality issues, to ensure production of safe and effective medical devices.
• Work collaboratively with Operations and R&D project teams to develop and implement appropriate risk management, qualification, verification, and validation plans.
• Support Document Control initiatives and consult on continuous improvement activities involving the document control program; assist with eQMS activities.
• Manage activities and procedures associated with the Device Master Record (DMR) and Device History File (DHF); support all activities with the batch records/device history record (DHR).
• Assist with maintaining the Risk Management Files and participate in Risk Analysis of changes; lead efforts with completing a full risk assessment of the receiving, kitting, and shipping of products (PFMEA/Risk Analysis).
• Assist with maintaining and managing the Software Lifecycle requirements per IEC 62304.
• The employee may be asked to perform other tasks related to his/her competence.

• Bachelor's degree & 3 years' directly related experience.

• Bachelor's degree, or equivalent combination of training and/or experience in Science, Engineering, or Manufacturing-related field.
• 5+ years' quality engineering experience.
• 3+ years' medical device experience.
• Auditing experience in quality assurance requirements associated with medical devices.
• ISO 13485 Certified Lead Auditor or CQA.
• Understanding of inputs, outputs, raw materials, waste, quality control, costs, and techniques for maximizing the manufacture and distribution of goods.
• Strong project management skills, as well as an ability to multi-task.
• Ability to write reports, business correspondence, and procedures.
• Ability to respond internally to common inquiries or complaints from customers, regulatory agencies, or members of the business community.
• Ability to effectively present information to top management, groups and/or board of directors.
• Thorough knowledge of FDA Quality System requirements, ISO 13485:2016 (Quality System) requirements, ISO 14971:2019 (Risk Management) requirements, Medical Device Regulation (MDR) requirements, and Current Good Manufacturing Practices (cGMP).
• Experience with IEC 62304 Software Lifecycle…