Job Description

Who we want

* Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
* Dedicated achievers. Relentless about quality, people who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
* Self-directed initiators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
* Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.

What you will do

Stryker is one of the world's leading medical technology companies and is dedicated to helping healthcare professionals perform their jobs more efficiently while enhancing patient care. The We are currently seeking a Quality Management Systems Lead Specialist to join our Stryker Joint Replacement team in Mahwah, NJ.

As a Quality Management Systems Lead Specialist you will collaborate with all functions of the business in a highly visible role. You will manage the External Standards process to ensure our QMS is compliant with all applicable regulatory requirements and that our product portfolio is State of the Art (SOTA). This role will lead strategic discussions around quality improvements and establishment of best practices. This role will also be held accountable for the organization of external audits by applicable regulatory authorities including planning, execution, and post-audit follow-up.

* You will lead all aspects of the External Standards process to ensure Stryker is meeting State of the Art (SOTA) requirements
* You will be responsible for partnering with cross functional teams to develop robust and risk-based solutions to complex standards requirements
* You will lead all External Standard remediation activities so that our product portfolio meets all current requirements
* You will plan and support all elements of external audit planning, execution and close out / follow-up
* You will support QMS compliance with the appropriate internal and external regulatory requirements and maintain awareness of the overall regulatory landscape.
* You will maintain the divisional Quality Manual, Quality Plans and Quality Policy, ensuring they are reflective of changes in business scope, QMS and regulatory requirements, and appropriately utilized throughout the division.

What you need

* Bachelors degree in engineering, science or related discipline
* Minimum of 4 years experience in a regulated industry preferred
* Extensive knowledge of US and International Medical Device Regulations and Standards including but not limited to: FDA: CFR 21 Part 820 (QSR), Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 (EU MDR), ISO 13485 (International Organization for Standardization) very highly preferred.