Sr. Quality Engineer

Intuitive•Durham, NC

21h

About The Position

This position reports through the Professional Education and Program Services (PEPS) organization and supports the Advanced Tissue Models team. The role establishes and improves quality control in product manufacturing and design control by implementing quality metrics and actions to reduce defects and meet quality objectives. It supports the design and development, procurement of materials, manufacturing, rework, and distribution of porcine-derived and synthetic surgical training tissue models, as well as distribution of supporting equipment. The position’s initial allocation is approximately 60% supporting new product development, 25% sustaining manufacturing operations, and 15% quality advocacy and continuous improvement. Responsibilities span design controls, risk management, verification and validation, manufacturing support, quality-system effectiveness, audits, failure analysis, and process improvement. The role works cross-functionally and escalates issues that could affect compliance, patient safety, or surgical efficacy.

Requirements

Demonstrated proficiency in 21 CFR 820, ISO 13485, and ISO 14971 requirements for process or design changes.
Understanding of product risk management and experience generating or updating FMEAs.
Understanding of Design Controls, Change Controls, and product and engineering processes.
Proficiency in generating and executing qualification and validation protocols and Quality Assurance Procedures.
Experience leading root-cause analyses, product containment, and rework activities.
Proficiency in SPC and Six Sigma methods and tools, including DMAIC and basic tools such as 5 Whys, control charts, and fishbone diagrams.
Understanding of Excel data analysis operations such as Pareto analysis, charting, and trend analysis.
Ability to think independently and make decisions with limited information.
Effective verbal and written communication skills.
High ethical and moral standards and appropriate personal conduct in decisions, communications, actions, and dealings with others.
Ability to work independently and manage tasks with competing priorities.
Bachelor’s degree in Engineering, Mathematics, Physics, Life Sciences, or a related discipline.
At least 8 years of Quality Engineering experience in a manufacturing environment, including at least 4 years in the medical device industry; alternatively, at least 6 years of experience with an advanced degree.

Nice To Haves

Advanced degree.

Responsibilities

Support planning and execution of design controls, risk management, and design verification and validation for system and subsystem design changes.
Participate in risk management activities, ensuring risks are identified and assessed and risk management files are updated.
Ensure design changes follow company standards and applicable regulations; recommend design processes and methods to meet quality goals, including DFX.
Support manufacturing processes, failure analysis, and defect and scrap containment, and ensure manufacturing activities follow procedures and USDA regulations.
Support development and execution of process validation and verification test plans, protocols, and reports.
Maintain and update site-level process risk management files.
Support production ramp-up, work cross-functionally to resolve issues, and drive continuous improvement projects.
Investigate and disposition internal and supplier-related defects.
Develop and apply corporate-level quality metrics; help ensure quality-system requirements are established and maintained effectively.
Lead and manage quality initiatives in product and process quality areas.
Review non-conformance data, identify trends and root causes, and drive improvement projects through implementation and closure; proactively use data to mitigate potential issues.
Support internal and external audits, including preparation, review of front-room documents, and interaction with auditors.
Perform risk analysis and determine quality dispositions for variance requests and non-conformances.
Approve process and document changes through engineering change orders and deviations.
Escalate issues or potential issues that could affect compliance, patient safety, or surgical efficacy.
Ensure department projects are completed successfully and on time, and communicate constraints that put completion at risk to management.
Perform detailed technical failure analysis based on physics of failure and interpret complex data using knowledge of product hardware and software, failure physics, and clinical or operating-room use conditions.
Perform other duties as assigned by management.