Senior Staff Quality Engineer - Design Assurance What you will doThis role will lead and evaluate risk management and usability activities and systems for Joint Replacement products currently in the field in accordance with ISO 13485, ISO 14971 and IEC 62366.
This role will define strategy and partner with technical and managerial leaders on emerging issues (NC/CAPA, Regulatory Requests), Joint Replacement Lifecycle Management (Product Transfers, Supplier Initiated Change Requests), and Base Business Requests (Risk Management Periodic Review, EUMDR Compliance, Health Risk Assessments).
Proficient in risk management practices and tools, having high expertise in failure modes associated with production and production-related processes (PFMEA).
Support the Risk Management File through risk Management Principles.
Responsible for the evaluation of process risks, risk mitigation and ensures appropriate production and process controls are identified, qualified, and implemented throughout the product manufacturing lifecycle (from incoming of materials/components, manufacturing, until product release) through robust pFMEA.
Ensure all Risk Management outputs comply with ISO14971.
Support Design team to complete CQA/CTQ identification and inputs to dFMEA.
This role will evaluate and influence guidance documents and internal trainings to cross functional teams on areas of experience for risk management and usability, as well as present externally in audits on our risk management files.
This role will seek out and drive collaboration with cross functional partners from various groups including Product Development, Regulatory, and Clinical to solve technical problems regarding our existing orthopedic products.
This role will represent Design Assurance and direct risk management strategy in global initiatives to improve the cost and manufacturing on Stryker devices.
This role will identify, evaluate and lead continuous improvements projects within the Design Assurance team to implement new efficiencies into daily deliverables and large-scale tasks.
This role will be a part of a global team that drives engineering activities in the maintenance of orthopedic products to ensure the highest level of product quality and ensure compliance to the company's quality system and external standards.
This role will be on a team whose mission is to efficiently drive rigor in Sustaining activities through creative problem solving and ensures market continuity of safe and effective products.
What you need:Required: Minimum of 6 years experience in quality, engineering and/or risk management in a highly regulated industry.
Bachelor's Degree in engineering.
Experience with ISO 13485, ISO 14971 and/or IEC 62366.
Experience in quality concepts (risk management, audits, NC/CAPA, HRAs).
Strong interpersonal skills, written communication, and oral communication.
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