Job Information
Stryker Staff Engineer, Quality Assurance in Cork, Ireland
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 (https://www.strykercareersblog.com/post/8-reasons-to-join-strykers-engineering-team )
This is initially a 23 month Fixed Term Contract
Who we want
Detail-oriented process improvers . Critical thinkers who naturally see opportunities to develop and optimize work processes - finding ways to simplify, standardize and automate.
Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.
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. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
- Strategic thinkers . People who enjoy analyzing data or trends for the purposes of planning, forecasting, advising, budgeting, reporting, or sales opportunities.
What you will do
Will work within the quality operations team, under minimal supervision, with responsibility for quality related activities, including, but not limited to the following:
Work closely with operations and the business functions to ensure quality performance of product and processes.
Oversight and approval of NC & CAPA, activist and mentor in problem solving and root causing activities.
Lead and participate in the development and improvement of the manufacturing processes for existing and new products.
Analysis and review of concession requests.
Review and approval of change management activities.
Maintain KPI for monitoring of process quality, perform analysis and interpret trends, take action as necessary.
Support execution and analysis of QATs.
Advocate of Human Factor practices, proficient in the science of Human Factor identification and mitigation.
Proficient in risk management practices and tools, having high expertise in process risk.
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.
Support First Article Inspections.
Proficiency in statistical methods and application.
Participate and interface in internal & external audits with regulatory representatives, providing effective narrative and description of topic of expertise.
Assist in the development, responsible for review & approval of process and equipment validation/qualification.
Support manufacturing transfers to other plants/facilities, leading quality activities.
Responsible for initiation, management and support of Ship, Product Holds, potential product escapes.
Coach and mentor others in quality topics and activities.
What you need
This job would suit someone working in a quality engineering role or similar looking to progress their career
Bachelor degree in Science, Engineering or equivalent/ related subject (Level 8)
Ideally a minimum of 2 or more years experience
Previous experience in a regulated environment desirable.
CQE or equivalent course work / experience desirable.
Proficient in understanding of Med Device manufacturing processes desirable.
Familiarity with ISO 13485, GDP, GMP desirable.
Lean Six Sigma training a distinct advantage.
Working knowledge/experience of Risk Based and statistical techniques, in particular process risk, statistical sampling plans, Process Capability, Gauge R&Rs.
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 (http://www.stryker.com./)
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.