Quality Engineer II

About the Role

The Quality Engineer, as part of a cross-functional team, ensures that applicable elements of the Quality System and external standards are followed. This role applies quality best-practices, including team-based and statistical tools, strong root cause analysis, and promotes these tools throughout the organization. The Quality Engineer leads and executes projects of varying complexity, connecting well with all levels of the organization from operators and inspectors to management, with minimal oversight required.

Responsibilities

• Executes Quality Engineering activities related to Operational support, including 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 actions.
• Supports Non-Conformance (NC) and Complaints/CAPA/SCAR systems within the Quality Engineering Team.
• Uses 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.
• Works closely with the Quality Control team to ensure adequate resources to support manufacturing.
• Ensures compliance with all practices in accordance with the Quality Management System.
• Provides technical support for process improvements, supplier changes, or design changes, including updates to risk management documentation and ensuring comprehensive records are produced.
• Works with quality control, manufacturing, and warehouse personnel to implement processes and process improvements, including related documentation.
• Executes control measures and drives resolution when supplier quality issues are identified.
• Supports supplier management principles such as supplier selection, qualification, certification, and performance improvement.
• Applies concepts of producer and consumer risk, including operating characteristic curves, AQL, LTPD, AOQ, AOQL, etc., and interprets sampling plans.
• Supports incoming inspection processes.
• Develops and validates test methods with oversight as needed.
• 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 and implements appropriate internal, national, and international requirements and standards.
• Performs internal and external audits (virtual and in-person), including supplier audits.
• Defines, identifies, and applies product and process control methods, such as developing control plans and work instructions.
• Contributes to corporate technical programs (e.g., system improvement, remediation, harmonization).

Requirements

• Bachelor’s degree in a STEM discipline or equivalent experience required.
• 3-6 years’ experience in the medical device or pharmaceutical field preferred.
• Technical knowledge and understanding of the medical device industry.
• Experience in risk identification, mitigation, and risk management.
• Prior supervisory experience is preferred.
• Experience with manufacturing processes and related documentation preferred.
• Minitab experience preferred.
• Experience with sterilization and packaging validation activities preferred.
• Experience in 3D modeling and drafting preferred.

Skills

• Self-directed, demonstrating ownership and accountability with an aptitude and willingness to learn.
• Team-oriented personality.
• Ability to plan, execute, control, and deliver on project tasks and overall goals.
• Strong written and verbal communication skills.
• Excellent problem-solving skills.
• Strong organizational skills.
• Collaborative personality with the ability to lead and influence others effectively without authority.
• 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, employing a risk-based approach.
• Ability to identify project and design risks and create mitigation strategies.
• Ability to independently make sound decisions with available information through a risk-based approach.
• Ability to analyze data using statistical methods.

Physical Requirements

• Regularly involves sitting, standing, walking, hearing/listening, repetitive hand movement, and vision requirements (close vision, adjust focus, color code).

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; multitask/re-direct; and experience numerous interruptions.

This position requires maintaining the highest standards of professional maturity and emotional intelligence, even in difficult or stressful situations.

Other Requirements

• Some US travel may be necessary (<10% time).

Work Environment

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