Staff Quality Engineer - Flower Mound, United States - Stryker

Description

Work Flexibility:

HybridStryker is hiring a Staff 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. Our Staff Quality Engineers maintain our brand of high-quality products.

As a Staff Quality Engineer, you will work with a team passionate about resolving product issues, improving product quality, and participating in design improvement projects.

Work Flexibility:
Hybrid. This role requires reasonable proximity to our Stryker facility in Flower Mound, TX. You should be comfortable working 3+ days a week 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:
Reviews and determines reportability of complaints to FDA and international regulatory authorities.
Supports the review and filing of Medical Device Reports (MDRs) and international Vigilance Reports.
Works closely with Sales Representatives and health care professionals to obtain additional information.
Monitors quality, completeness, and timeliness of complaint investigations.
Writes customer response letters.
Contributes to achieving team performance metrics and goals.
Collect data from multiple sources such as Trackwise and translate the data into meaningful Power BI Dashboards and visualizations.
Author and peer review Post market plans/reports on products sold worldwide.
Provide technical expertise in data analysis, data preparation and performance monitoring.
Build, manage and maintain reports, dashboards and visualizations as needed.
Communicate key findings to business partners and leadership throughout the organization.
Help develop automated solutions for dashboard and report generation.
Lead risk management activities to ensure the highest level of product and process quality.
Lead quality system maintenance by identifying and correcting deficiencies in procedures and practices.
Partner with cross-functional project teams to lead product and/or process improvements.
Utilize standard statistical analysis and problem-solving techniques to determine product acceptance limits, establish process parameters, resolve quality problems, etc.
Develop, review, and approve inspection plans, routers, and product drawings for new products.
Provide support and direction for other Quality Engineers.
Participate in collection of initial market feedback, provides complaint's data on new products and address early concerns.
Contribute to the completion of final design verification and validation.


What you need:

RequiredBachelors of Science in Engineering or related discipline4+ years of experience in Quality EngineeringPreferredDesign Quality Engineering experienceStrong knowledge in testing and Verification & Validation (V&V)Experience working in a regulated industry (Medical Device Manufacturing is strongly preferred)Electrical/Mechanical engineering experience preferred.

Lean manufacturing experience is strongly preferred.
Must be willing to work as part of a multi-site team, with some travel required.
Have a good understanding of engineering and quality concepts / theories. Familiarity with ISO 13485, GDP, GMP conceptKnowledge of Risk Based and statistical concepts.


Knowledge of Solid WorksTravel Percentage:
30%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.