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Staff Engineer, Quality Assurance (Supplier) Full Time

at Stryker Belfast in Belfast (Published at 06-04-2022)

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

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.

Position Summary

Provide quality engineering support in quality assurance, control, and preventative activities with a focus on continuous improvement of internal products and processes. Support supplier quality issues impacting daily operations. Advocate and lead the execution of initiatives and projects to enhance quality performance within the business and for our customers. Mentor and provide technical direction across multiple areas of expertise. Ensure compliance to regulation and standards.

What you will do:

  • Work closely with operations and the business functions to ensure quality performance of product and processes

  • Collaborates with Divisional QA, cross functional and suppliers? teams to address top quality issues

  • Own identified internal and supplier non-conformances and manage the timely closure of NC?s

  • Own or support identified internal CAPAs and manage to timely root cause investigation, implementation and closure

  • Disposition non-conforming product within MRB, issuing NCs as appropriate

  • Communicate and collaborate with suppliers regarding non-conformances, escalating supplier corrective actions requested as required

  • Engage in the development and improvement of internal manufacturing processes for existing products

  • Performs critical assessment of internal and supplier proposed change management activities

  • Performs PPAP activities for supplier changes

  • Participates and may lead in the creation and/or review of new or modified procedures

  • Maintain KPIs for monitoring of process and/or product quality, perform analysis, and interpret trends, identifying and activating on appropriate actions as necessary

  • Support execution and analysis of manufacturing related complaints and product field actions

  • Support and drive Human factor practices, familiarity in the science of Human Factor identification, reduction and mitigation

  • Collaborate with appropriate stakeholders to identify and execute opportunities for supplier part certification

  • Develop understanding of risk management practices and concepts and applies knowledge to manufacturing operations.

  • Support the creation and maintenance of inspection methods and sampling.

  • Applies statistical methods of analysis and process control to current operations.

  • Engage and interface in internal and external audits providing subject matter expertise

  • Support the development and review of process and equipment validation/qualification and MSA of internal processes.

  • Execute internal quality deliverables associated with engineering changes, manufacturing transfers and supplier-initiated changes.

  • Support manufacturing transfers to/from other plants/facilities, executing appropriate quality activities.

What we are looking for:

  • BSc / BEng in a science, engineering or related discipline.

  • MS, CQE, or CRE preferred.

  • Experience in Electronics preferred

  • Six Sigma Green or Black belt preferred.

  • Minimum of 5 years experience preferred.

  • 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 the project teams

Know someone at Stryker?

Be sure to have them submit you as a referral prior to applying for this position. Learn more about our employee referral program at https://careers.stryker.com/referrals/

About Stryker

Stryker is one of the world?s leading medical technology companies and, together with our customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes.

We are proud to be named one of the World?s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine! Learn more about our award-winning organization by visiting stryker.com

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