Sr. Quality Engineer

Job Description POSITION SUMMARY

The Sr. Quality Engineer plans and conducts activities concerned with the quality assurance of industrial processes, materials, and products. The Sr. Quality Engineer will be responsible for ensuring the highest quality standards in our products and processes, working closely with cross‑functional teams to develop, implement, and maintain quality assurance protocols that comply with regulatory requirements and industry standards. The Sr. Quality Engineer will possess a deep understanding of quality management systems, regulatory requirements, and risk management principles.

The Sr. Quality Engineer will report directly to the Quality Engineering Manager.

• Actively participates in defining customer requirement, product claims, and target markets early in the product development lifecycle.
• Performs quality engineering reviews of design documentation for compliance with stated requirements.
• Leads complex technical problems where analysis of situations or data requires an in-depth evaluation of various factors and solves a wide range of difficult problems in creative and effective ways.
• Develops or participates in establishing requirements for all verification and validation (design and process) activities.
• Applies state-of-the-art inspection and quality engineering/assurance techniques, procedures, instruments, equipment, theories, principles, and concepts to products and processes.
• Leads development of Risk Management documentation.
• Leads or participates in data collection, analysis, trending and reporting on non‑conformances and investigations to determine root cause, corrective and preventive actions.
• Mentors junior Quality Engineers as required.
• Participates in internal and external audits and inspections.
• Maintains process and software validation plans. Writes validation protocols. Facilitates completion of validation activities, performs data analysis, and writes the validation report.
• Prepares reports to communicate involvement and results of quality assurance and quality engineering activities.
• Prepares and presents technical and program information to team members and management.
• Directs technical and administrative workers engaged in quality assurance activities.
• Applies statistical analysis of data to evaluate the current process and process changes.
• Maintains a working knowledge of FDA GMP, ISO 13485 standards and other applicable standards.
• Documents data obtained during all quality assurance activities, consistent with company policies and procedures.
• Reviews all purchased products or components and provides input to the decision of whether to accept the product and future purchases from the vendor.
• Supports Regulatory Affairs with their activities related to submissions and notified body filings.
• Develops an understanding of Envista Business System (EBS) processes and tools and utilizes them in the execution of projects (i.e., Problem‑Solving Process (PSP) and Visual Project Management (VPM)).
• Completes any duties or tasks assigned by Supervisor/Manager.

• Bachelor's degree (B.S.) in Engineering or a related field.
• 5 years of experience in quality engineering within the medical device industry.
• FDA Quality System Regulation Part 820 and ISO 13485 experience.
• Certified Quality Engineer preferred.

• Master’s Degree in a related field preferred.
• Effective interpersonal communication skills and able to interface with cross‑functional teams.
• Possess critical thinking skills and able to be assertive and challenge the process in a diplomatic manner.
• Strong verbal, written and interpersonal skills (explains difficult or sensitive information; works to build consensus); able to explain technical terminology in layman’s terms to product development groups, peers, and senior management.
• Highly organized with a detail‑oriented mindset.
• Portrays flexibility and multi‑tasking in a dynamic environment with changing priorities.
• Adaptable to work with software‑based development and automated processes.
• Communicates significant issues or developments identified during quality assurance activities and…