Compliance Engineer Belfast, Northern Ireland
Job description
Why engineering at Stryker?
At Stryker we are dedicated to improving lives, with a passion for researching and developing new medical device products. As an engineer at Stryker, you will be proud of the work that you will be doing, using cutting-edge technologies to make healthcare better. Here, you will work in a supportive culture with other incredibly talented and intelligent people, creating industry-leading medical technology products. You will also have growth opportunities as we have a culture that supports your personal and professional development.
Need another reason to apply? Check out these 8 reasons to join Stryker's engineering team: https://www.strykercareersblog.com/post/8-reasons-to-join-strykers-engineering-team
Job Description SummaryProvide Quality Assurance (QA) and Quality Engineering (QE) support to existing and new product development projects. Serves as a subject matter expert for Product Safety/Product Environmental Compliance as well as the requirements and processes that result in the integration of the voice of the customer into the design and realization of products. Supports the successful integration of validation considerations into design control.
This is an individual contributor role that requires the use of judgement in applying professional expertise and is expected to work independently with minimal supervision. Roles typically require a university degree or an extensive amount of practical knowledge gained through experience. Job requires an understanding and application of procedures and concepts of own discipline. The job requires the ability to make judgements based on practice and previous experience. This job typically requires a degree or equivalent and no experience.- Responsible for administration of the standards and regulations process
- May support audits and primary audit contact for team
- Manage and maintain existing environmental stewardship systems, programs and processes
- Plan, develop, implement, document, train, communicate and monitor compliance with international, federal, state, and local product environmental regulations and product compliance standards
- Experience and understanding of risk management concepts
- Experience and understanding of design validation concepts
- Oversee and / or execute submission of required reports to the regulating authorities including reporting under Directives such as Waste Electrical and Electronic Equipment (WEEE), Battery, and Packaging
- Review and evaluate test data, specifications, engineering and user documentation, physical construction, marking and labeling, hazard analysis, clinical reports, Declaration of Conformity, EMC protocol and test reports and, the technical description of essential components and materials
- Provides content for the preparation and revision of Technical Document Files and other certification reports
- Prepare Standards & Regulations Management Board presentation
- Facilitate site specific Standards and Regulations reviews, compile and maintain documentation
- Perform Quality Engineering related duties as needed including data analysis/trending, test report reviews, design failure analysis and risk management tasks
- Perform other duties as assigned
About Stryker
Stryker is one of the world’s leading medical technology companies and, together with our customers, is driven to make healthcare better.
The company offers innovative products and services in Medical and Surgical, Neurotechnology, Orthopedics, and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 100 million patients annually.
More information is available at stryker.com
