Senior Quality Engineer (Hybrid)

Work Flexibility : Hybrid

Stryker is hiring a Senior Quality Engineer (Hybrid) in Flower Mound, Texas, home to Stryker Communications! Our communications team is dedicated to optimizing care environments through the iSuite integrated operating room.

As part of the Quality team, customers and patients are at the heart of everything we do.

In this role, you will provide quality engineering guidance in quality assurance, control, and preventative activities, focusing on continuous product and process improvement.

You will lead quality initiatives and projects to enhance quality performance within the business and for our customers while ensuring compliance with regulations and standards.

We are looking for an engineer who is passionate about innovation, being part of new product development, and ensuring product quality.

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

Who we want :

User-focused creators. Engineers who design with the user in mind, developing medical devices that help change patients’ lives.

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. (DD).

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.

Advocate of Human Factor practices, proficiency in the science of identification of mitigation.

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.

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 need : Required

Required

Bachelor of Science, Engineering or related discipline required. Mechanical background strongly preferred.

2+ years of experience in Engineering

Design experience required.

Preferred

MS, CQE, or CRE preferred.

Ideal candidates will have exposure to various technical areas, including (but not limited to) : New Product Development, Product Quality, Risk Assessment, Risk Management, Design Assurance, Design Verification and Validation, Defect Reviews, Product Reliability and Durability.

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.

High proficiency in statistical methods and application.

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.

Demonstrated ability to successfully manage and complete projects in a matrix organization.

Experience in working in a compliance risk situation

Travel Percentage : 20%Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status.

Stryker is an EO employer M / F / Veteran / Disability.Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant.

However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.