QA Engineer
Harrisburg, NC Quality and Regulatory Assurance
Job Type
Full-time
Description

Job Summary

The Quality Engineer, as part of a cross-functional team, with primary responsibility for quality management related to Operational support, ensures that applicable elements of the Quality System and external standards are being followed. As the voice of Quality, the Quality Engineer applies quality best-practices including team-based and statistical tools and techniques and promotes the value and use of such tools throughout the organization. 

Essential Job Functions

  • Leads Quality Engineering activities in relation to Operational support, including support of risk management creation, classification of quality characteristics, technical drawings and specifications, design verification and validation, and process validation activities.
  • Performs root cause analysis of identified issues and identifies appropriate corrective and preventive action. Functions as the site-owner for NC and Complaints/CAPA/SCAR systems. 
  • Uses appropriate statistical tools such as collecting and summarizing data, drawing conclusions with confidence, determining sample sizes, applying Statistical Process Controls (SPC), identifying relationships between variables, and statistical decision making.
  • Supports activities related to clean room monitoring and environmental controls.
  • Ensures compliance with all practices in accordance with the Quality Management System. Ensures comprehensive documentation is available, adequate records are produced, and change management is implemented for product changes.
  • Implements control measures and drives resolution when supplier quality issues are identified. 
  • Applies supplier management principles such as supplier selection, qualification, certification, and performance improvement. 
  • Applies the concepts of producer and consumer risk and related terms, including operating characteristic curves, AQL, LTPD, AOQ, AOQL, etc. Interprets and selects variable, attribute, and zero-defect sampling plans. Supports incoming inspection processes. 
  • Develops and validates test methods. Identifies and applies metrology techniques such as calibration systems, traceability, measurement error, and control of standards and devices. Conducts measurement system error studies such as Gage R&R.
  • Understands the implementation of appropriate internal, national, and international requirements and standards. Performs internal and external audits as necessary (virtual and in-person).
  • Defines, identifies, and applies product and process control methods such as developing control plans, identifying critical control points, and developing and validating work instructions.
  • Contributes to corporate technical programs (e.g., system improvement, remediation, harmonization) in areas such as those identified in this position description.

Qualifications

  • Bachelor’s degree in a STEM discipline required.
  • 2+ years’ experience in the medical device or pharmaceutical field. 
  • Technical knowledge and understanding of the medical device industry.
  • Experience in 3D modeling and drafting preferred.
  • Experience with sterilization and packaging validation activities preferred.
  • Minitab experience preferred.

Competencies

  • Self-directed, demonstrating ownership and accountability with an aptitude and willingness to learn.
  • Demonstrates the ability to plan, execute, control, and deliver on project tasks and overall goals.
  • Strong written and verbal communication skills.
  • Collaborative personality with the ability to lead and influence others effectively while creating and maintaining a positive environment.
  • Ability to develop and maintain relationships with medical professionals, sales force, and cross functional team members.
  • Understanding of change management, conflict resolution and team dynamics.
  • Excellent critical thinking skills, including experience implementing the DMAIC thought process and structured root cause analysis.
  • Ability to identify project and design risks and create mitigation strategies.
  • Ability to independently make sound decisions with available information.
  • Ability to analyze data using statistical methods.
Requirements

Physical Requirements

Performing the duties of this job regularly involves sitting, standing; walking; hearing/listening, repetitive hand movement; vision requirements - close vision, adjust focus, color code

Mental Requirements

This position requires the ability to: maintain an appropriate work pace; comprehend and follow instructions; exercise logic and reasoning; organize and prioritize; read; compose written communication; communicate verbally; problem solve and make decisions; count and compute,) analyze and interpret data; multi-task/re-direct; experience numerous interruptions. This position requires the ability to maintain the highest standards of professional maturity and emotional intelligence even in difficult or stressful situations

Other Requirements

Some US and International travel may necessary (<15% time)

Work Environment

The noise level in the work environment is usually; (1) quiet to moderate. Occasionally this position will be in a lab or machine shop environment where the noise level will be loud.