Sr. Quality Engineer

Required Skills and Experience

• Demonstrated proficiencies of 21 CFR 820, ISO 13485 and ISO 14971 requirements for making process or design changes.
• Understands product risk management, experience in generating/updating FMEAs.
• Understands Design Controls, Change Controls, Product, and Engineering Processes.
• Proficient with generation and execution of Qualifications, Validation protocols and Quality Assurance Procedures.
• Experienced in leading root cause analyses, product containment, and rework activities.
• Proficient in SPC & Six Sigma methodology and tools (e.g. uses DMAIC process and basic tools such as 5 Why's, control charts, fishbone diagram).
• Understands typical Excel data analysis operations (e.g. Pareto, charts, and trends).
• Capable of thinking independently and making decisions based on limited information.
• Ability to communicate effectively both verbally and in writing.
• Accepting and adhering to high ethical, moral, and personal dealing with others values in decisions, communications, actions, and when dealing with others
• Ability to work independently and handle tasks with competing priorities effectively.

• Initial roles and responsibilities for this position will include the following:

• Product development:
  • Strong contributor to the planning and execution of design controls, risk management, and design verification/validation for design changes for system and subsystems.
  • Participate in risk management process ensuring that risks are properly identified/assessed and risk management files are updated accordingly.
  • Ensure design changes are established and implemented according to ISI standards and applicable regulations.
  • Recommend design processes and methods to meet quality goals (DFX, etc.).
• Manufacturing support:
  • Support manufacturing processes, including failure analysis and defect/scrap containments.
  • Ensure manufacturing activities follow procedures and comply with USDA regulations.
  • Support development and execution of process validation and verification test plans, protocols, and reports, as needed.
  • Maintain site level process risk management files and update as required.
  • Support production ramp, work cross functionally on issues and drive continuous improvement projects.
  • Support investigation and disposition of defects, both internal and supplier related.
• Quality Advocacy:
  • Develop and apply corporate-level quality metrics.
  • Ensure the quality system requirements are effectively established and maintained.
  • Lead and manage quality initiatives in one or more areas of product and processes quality.
• Continuous Improvement:
  • Review line non-conformance data and identify the trends and drive the continuous improvement projects including identifying the root cause, implementation and closure.
  • Review data proactively and take actions to mitigate issues from occurring.
• Support internal and external audits, including audit preparation, reviewing the front room documents and interacting with the 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/potential issues to direct management that could impact compliance, patient safety or surgical efficacy.
• Ensure successful, on-time completion of department projects, communicate constraints to direct management when successful project completion is at risk.
• Perform deep technical failure analysis based on the physics of failure.
• Review and interpret complex data analysis rooted in an understanding of our product hardware and software, the physics of failure, and the use conditions in the clinical / operating room environment.
• Performs other duties as assigned by management.