Sr. Quality Engineer

Position Summary

The Sr. Quality Engineer plans and conducts activities concerning the quality assurance of industrial processes, materials, and products. The incumbent 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 role requires a deep understanding of quality management systems, regulatory requirements, and risk management principles, and reports directly to the Quality Engineering Manager.

• Actively participates in defining customer requirements, 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 problem analysis 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/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 validation activities, performs data analysis, and prepares validation reports.
• 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 activities related to submissions and notified body filings.
• Develops an understanding of Envista Business System (EBS) processes and tools and utilizes them in project execution.
• Performs any duties or tasks assigned by Supervisor/Manager.

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

• Master’s degree in a related field preferred.
• Effective interpersonal communication skills and ability to interface with cross‑functional teams.
• Critical thinking skills and ability to be assertive while maintaining diplomatic relations.
• Strong verbal, written, and interpersonal skills; ability to explain technical terminology in layman’s terms.
• Highly organized with a detail‑oriented mindset.
• Flexibility and multitasking ability in a dynamic environment with changing priorities.
• Adaptable to software‑based development and automated processes.
• Communicates significant issues or developments identified during quality assurance activities and recommends process improvements to management.
• Works well in a cross‑functional team and speaks up to guide other team members.
• Solves complex problems; takes new perspectives on existing solutions; exercises judgement based on analysis of multiple information sources.
• Proactively influences designs to achieve product quality and reliability targets that meet or exceed customer expectations.
• Strong computer skills with knowledge of…