Senior Quality Engineer(Hybrid) - Installation Quality

Stryker is hiring a Senior Quality Engineer (Hybrid) - Installation Quality in Flower Mound, Texas, home to Stryker Communications!

Join a dedicated team overseeing installation quality across the Communications BU. As a Senior Quality Engineer, you will lead installation quality activities for all Communication products, including integration, and be responsible for driving the systemic elimination of installation and service-related issues. You will also advocate for and lead initiatives and projects to enhance quality performance within the business and for our customers.

Work Flexibility: Hybrid. This role requires reasonable proximity to our Stryker facility. You should be comfortable working three days onsite.

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.
• 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:

• Work closely with operations and the business functions to ensure quality performance of product and processes. (SGS).
• Work closely with customers, sales/marketing/field personnel, and cross-functional teams to address top quality issues.
• Mentors, provides oversight and approval of NC/CAPA, activist and high-level expert in problem-solving and root-causing activities.
• Initiates and leads in the development and improvement of the manufacturing processes for existing products. (SGS).
• Oversight and leads investigations during concession management. (SGS).
• Review and approval of change management activities, challenges effectiveness and drives strong review.
• Interpret KPI trends, drive continuous improvement process.
• Subject matter expert in risk management practices and concepts.
• Develop and provide input by identifying opportunities and weaknesses.
• Proficiency in and provides technical direction in optimization of inspection methods and sampling.
• High proficiency in statistical methods and application.
• Engage in and may lead internal and external audits with regulatory representatives, providing effective narrative and description of topic of expertise and overview of the business. May manage audit logistics and/or preparation.
• Aids in the development of validation strategies for existing products. (SGS).
• Support manufacturing transfers to other plants/facilities, leading quality activities. (SGS).
• Responsible for initiation, internal containment, and support of ship and product holds for potential product escapes.
• Coach and mentor others in quality topics and activities.

What you will do:

Required:

• Bachelor of Science, Engineering or related discipline required. Mechanical or electrical degree preferred.
• 2+ years of related experience.

Preferred:

• Project Management experience preferred.
• Field experience is a plus.
• Experience with analyzing nonconformances.
• MS, CQE, or CRE preferred.
• Six Sigma Green or Black belt preferred.

• Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.) desired.
• Understanding of US and International Medical Device Regulations.
• Familiarity with ISO 13485, GDP, GMP required.
• Strong knowledge of Quality Concepts (e.g. Risk Management, CAPA, Audits, Statistics).
• Must possess strong communication, project management and influencing skills as well as have the ability to manage multiple tasks simultaneously.
• Ability to represent Quality function within and across project teams.
• Strong interpersonal skills, written, oral communication and negotiations skills.
• Strong in critical thinking and ""outside the box"" thinking.
• Highly developed problem-solving skills. Strong analytical skills.
• Demonstrated ability to successfully manage and complete projects in a matrix organization.
• Experience in working in a compliance risk situation.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.