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Why join Stryker?
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Stryker is hiring a Senior Staff Quality Engineer in Mahwah, New Jersey, to support Joint Replacement! In this role, you will collaborate with various internal stakeholders to improve product quality, identify continuous improvement opportunities, and provide technical/compliance support.
Who we want:
Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.
Effective communicators. People who can interpret information clearly and accurately to concisely communicate results and recommendations to stakeholders, senior management, and their teams.
What you will do:
Build relationships with various divisions/business units the manufacturing facility builds product for.
Drive continuous improvement opportunities in the Quality Assurance area, including cost reduction opportunities. Previous Lean experience preferred.
Advocate for and lead the execution of initiatives & projects to enhance quality performance within the business and ensure compliance to regulation and standards.
Work closely with operations and the business functions to ensure quality performance of product and processes.
Provide oversight and approval of NC & CAPA, mentor in problem solving and root causing activities.
Coach, mentor, and assist in development of less experienced engineers.
Work collaboratively with operations & strategic partners, such as Manufacturing, Engineering, and Supply Planning to achieve strategic initiatives
Participate and interface in internal & external audits with regulatory representatives, providing effective narrative and description of topic of expertise.
Ensure regulatory requirements are incorporated into projects and processes
Apply statistical methods to ensure reliability of the manufacturing process
Assist in the development, responsible for review & approval of process and equipment validation/qualification.
Responsible for initiation, management and support of Ship, Product Holds, potential product escapes
Develop and provide input for risk management by identifying opportunities and weaknesses.
Proficiency in and makes continuous strides towards optimization of inspection methods and sampling
What you need:
Required:
Bachelor of Engineering - Biomedical, Mechanical or related field required.
6+ years of experience is required.
Experience in a regulated industry required.
Preferred:
Internal Quality Auditor Qualification preferred (ISO 13485, CFR 820 or comparable industry standard and regulatory requirements).
Experience in a highly regulatory environment desirable.
Knowledge of PFMEA, validation programs and SPC processes.
Understanding of manufacturing prints and tolerancing.