Sr. Quality Engineer
About The Position
This position reports through the Professional Education and Program Services (PEPS) organization and enables the Advanced Tissue Models team to establish effective quality control in product manufacturing and design control. The role implements key quality metrics and actions to reduce defects and meet quality objectives. It supports design and development, material procurement, manufacturing, rework, and distribution of porcine-derived and synthetic surgical training tissue models, as well as distribution of supporting equipment. The role is expected to spend approximately 60% of its time supporting new product development, 25% sustaining manufacturing operations, and 15% on quality advocacy and continuous improvement. It contributes to design controls, risk management, and design verification and validation; supports manufacturing processes and regulatory compliance; leads quality initiatives; and uses data analysis and technical failure analysis to identify and address quality issues.
Requirements
- Demonstrated proficiency with 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, Product, and Engineering Processes.
- Proficiency 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 methodologies and tools, including DMAIC and tools such as 5 Whys, control charts, and fishbone diagrams.
- Understanding of typical Excel data analysis operations, such as Pareto analysis, charts, and trends.
- Ability to think independently and make decisions based on limited information.
- Effective verbal and written communication skills.
- High ethical and moral standards and integrity 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; the minimum is 6 years with an advanced degree.
Nice To Haves
- Advanced degree.
Responsibilities
- Contribute to planning and execution of design controls, risk management, and design verification and validation for design changes to systems and subsystems.
- Participate in risk management, ensure risks are identified and assessed, and maintain risk management files.
- Ensure design changes are established and implemented according to company standards and applicable regulations.
- Recommend design processes and methods to meet quality goals, including design for excellence practices.
- Support manufacturing processes, failure analysis, and defect and scrap containment.
- Ensure manufacturing activities follow procedures and comply with USDA regulations.
- Support development and execution of process validation and verification test plans, protocols, and reports.
- Maintain site-level process risk management files.
- Support production ramp, work cross-functionally on issues, and drive continuous improvement projects.
- Support investigation and disposition of internal and supplier-related defects.
- Develop and apply corporate-level quality metrics.
- Ensure quality system requirements are effectively established and maintained.
- Lead and manage quality initiatives in product and process quality areas.
- Review line non-conformance data, identify trends, and drive continuous improvement projects, including root-cause identification, implementation, and closure.
- Proactively review data and take action to mitigate potential issues.
- Support internal and external audits, including audit preparation, front-room document review, and interaction with auditors.
- Perform risk analysis and determine quality disposition 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 when project completion is at risk.
- Perform in-depth technical failure analysis based on the physics of failure.
- Review and interpret complex data analysis using knowledge of product hardware and software, failure physics, and clinical and operating-room use conditions.
- Perform other duties as assigned by management.
Benefits
- Market-competitive compensation package including base pay, incentives, benefits, and equity.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
