Quality Engineer
Job Details
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
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
Our benefits include bonuses; commissions; healthcare; insurance benefits; retirement programs; stock based plans; paid time off plans; family and parenting leaves; tuition reimbursement; wellness programs; onsite fitness centers and cafeterias; discount purchase programs; and service and performance awards – not to mention various social and recreational activities.
Who we want:
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.
Goal-oriented developers. Keeping the customer and system requirements squarely in focus, people who deliver safe and robust solutions.
Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.
Self-directed imitators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
User-focused creators. People who imagine with the user in mind, developing technology that helps change patients’ lives.
Stryker is hiring a Quality Engineer in Cary, IL.
What you will do:
As the Quality Engineer, you will develop and implement continuous improvement projects and participate in the performance of routine quality system functions.
- Provide quality related support to all areas of the plant as necessary
- Perform chemistry validations, including OOS (out of specification) and OOT (out of tolerance) and assist with lab investigation and root cause analysis
- Provide guidance and decision making on quality related issues as they arise
- Lead CAPA investigations including identification of root cause and corrective or preventive actions
- Collect and summarize data for investigations; perform trending analysis
- Author and/or revise Standard Operating Procedures as required
- Read and understand descriptions, communications, reports, tables, diagrams, directions, regulations, etc.
- Lead or participate Quality auditing as part of the Sage Quality System
- Lead or participate in or lead Quality improvement initiatives
- Effectively manage quality projects and ensure timely completion
- Maintain current knowledge of applicable domestic and international regulations
What you will need:
Basic Qualifications
- Bachelor's Degree in Engineering, Science or related field
Preferred Qualifications
- 1-2 years of experience preferred
- Lab investigation and root cause analysis experience is preferred
- ASQ Certification, Certified Quality Engineer or Certified Quality Auditor, preferred.
- Competent with Six Sigma tools and applications, Green Belt preferred.
- Relevant work experience in a cGMP regulated pharmaceutical or medical device environment
- Familiar with FDA regulations as they pertain to Sage Products, specifically 21CFR211 and 21CFR820
- Familiar with international standards and regulations as they pertain to Sage Products (i.e. Health Canada, MDD, ISO13485, etc.)
- Knowledge and skills in quality-related methods, techniques and application including problem solving, process management, assessment and metrics
- Effective written and verbal communication skills required
- Skills to manage multiple priorities with aggressive timelines and with a high level of productivity.
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 StrykerStryker 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