Staff Quality Engineer, Design & Reliability Assurance

Changing lives. Building Careers.

Joining us is a chance 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, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.

SUMMARY

The Staff Design Quality Assurance Engineer (DQA) is a subject matter expert responsible for the efficient and compliant support of New Product Development (NPD) and Sustaining/Remediation project(s) of varying scope and complexity in the Tissue Technology (TT) division, as well as risk management work for new and existing products.

The staff DAQ Engineer works with minimal supervision and guides the work of others to achieve assigned deliverables.

The role will interact with design and development partners, participating on cross-functional project teams through all phases of the product development process, and assisting the technical team with planning, executing, documenting, and communicating testing activities. The role works closely with Product Development, Project Management, Regulatory, Marketing, Manufacturing Facilities and Medical Affairs.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Work independently within broad guidelines, policies and the operational plan to impact a range of customer, operational, project or service activities within own team and other related teams

• Manage complex processes, lead the work of small project teams, Formally train and act as a resource for colleagues with less experience

• Support the design and development of new or improved products in close collaboration with Product Development, Project Management, RA, Marketing and Medical Affairs. Support Design Reviews, Technical Reviews, and Gate Reviews.

• Lead and support the execution of all Risk Management and Usability Engineering process activities, including design, process, and application FMEAs.

• Author or review for approval other Risk Management Documentation: PSRA, Risk Management Plan/Report, Hazard Analysis, Benefit-Risk Analysis (BRA).

• Support Internal partners in the development of products; including review and approval of development documentation such as product requirements, schematics, verification, and validation strategy/execution.

• Coordinate, review and approve development documentation created by external partners.

• Lead implementation of SPC programs with Manufacturing and Quality Control as a part of Process Validation and Design Transfer.

• Maintains knowledge of and applies statistical analysis to support >Additional Description for Pay Transparency:

  Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance, and savings plan (401(k)).

  Subject to the terms of their respective policies and date of hire, Employees are eligible for the following Total Rewards | Integra LifeSciences

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