Senior Engineer II, Quality

Integra LifeSciences

97d

About The Position

Changing lives. Building Careers. Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what’s possible and making headway to help improve outcomes. The Senior Quality Engineer II oversees the execution of the quality plans ensuring product realization is conducted in compliance with internal, customer and regulatory requirements during all phases of the product lifecycle. Under limited supervision and in accordance with all applicable federal, state and local laws/regulations, procedures and guidelines, this position: Reviews new and modified product design and manufacturing processes for quality characteristics, including manufacturability, serviceability, testability, reliability and conformance to product and quality system requirements. Develops and manages the product risk management process, including the development and maintenance of risk management files. Qualifies component and service suppliers, conducts supplier audits and ensures that appropriate supplier quality controls are implemented. Analyzes data and applies knowledge of engineering principles and practices to implement continuous improvement projects. Provides guidance to R&D, Operations and Quality on design and production/process controls, risk management, root cause analysis, validation and the application of statistical methods. Host business meetings with other functions within the organization including but not limited to Training, Human Resources, Manufacturing and Research and Development. May manage projects that involve other functions within the organization including but not limited to Training, Human Resources, Manufacturing and Research and Development. Responsible for communicating business related issues or opportunities to the next management level. Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable. For those who supervise or manage staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable. Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures. Performs other duties assigned as needed.

Requirements

• Bachelor’s degree in life science, engineering, physical science, or related field.
• At least 6 years of experience as a quality professional in an FDA-regulated industry, with at least 3 years in the medical device industry.
• In-depth knowledge of design control, risk management, production and process controls and applicable regulations (i.e., ISO 13485, FDA Quality System Regulation, ISO 14971).
• Working knowledge of and experience in the application of statistical methods.
• Excellent verbal and written communication skills.

Nice To Haves

• Advanced degree in life science, engineering, physical science, or related field.
• Process Excellence/Six Sigma certification.

Responsibilities

• Oversees the execution of the quality plans ensuring product realization is conducted in compliance with internal, customer and regulatory requirements.
• Reviews new and modified product design and manufacturing processes for quality characteristics.
• Develops and manages the product risk management process.
• Qualifies component and service suppliers and conducts supplier audits.
• Analyzes data and applies knowledge of engineering principles to implement continuous improvement projects.
• Provides guidance to R&D, Operations and Quality on design and production/process controls.
• Hosts business meetings with other functions within the organization.
• May manage projects that involve other functions within the organization.
• Communicates business related issues or opportunities to the next management level.
• Ensures compliance with all Federal, State, local and Company regulations, policies, and procedures.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Bachelor's degree
• Number of Employees: 1,001-5,000 employees