Senior Staff Engineer, Quality Assurance Engineering (R463987)
Stryker is driven to work together with our customers to make healthcare better. In order to fulfill our commitment as a federal contractor, while focusing on the health and safety of our employees and those that we serve, Stryker is encouraging US employees as well as all new US employees joining our company to be fully vaccinated against COVID-19. Today or in the future, vaccination may be a requirement based on the essential functions of the specific role or applicable regulations. Please refer to our COVID-19 Vaccination Requirements FAQs page for current vaccination and/or reasonable accommodation requirements and timelines.Why join Stryker?
We are proud to be named one 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.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
What you will do:
The Senior Staff Engineer, Quality Assurance Engineering provides technical leadership in the development and implementation of internal and external/supplier methods and procedures for process control, process improvement, testing and inspection to ensure that the products are free of flaws and function as designed and to ensure compliance to regulatory requirements. You will collaborate with supplier representatives on quality problems, ensure that effective corrective actions are implemented and contribute to supplier quality improvement programs.
Essential duties & responsibilities:
Provides technical leadership in the development and implementation of methods and procedures for process control, process improvement, testing and inspection.
Provides guidance in the design and installation of sophisticated testing equipment as well as in the data analysis methods to maintain quality levels and minimize defects and failure rates and recommend corrective actions as applicable
Leads quality assurance activities for development of process risk documentation.
Provides technical quality assurance guidance for investigations and resolution of product and quality system non-conformances.
Utilize standard statistical analysis and problem-solving techniques as necessary to determine product acceptance limits, establish process parameters, resolve quality problems, etc.
Identify supplier assessment requirements and communicate these to the supplier quality group.
Mentor other engineers on the application of quality tools.
Improve quality system to maintain FDA, as well as other applicable regulatory bodies, compliance.
Serve as Quality Assurance guardian for proposed process changes and improvements.
Stay abreast of applicable regulatory requirements and actively seeks out to understand current industry direction.
All other duties as assigned.
What you need:
Bachelor’s degree in Engineering
6+ years of work experience required
2+ years of experience in Quality Assurance or Quality Engineering for the medical device industry preferred
Knowledge of QSRs and ISO 13485 is required.
Ability to read and interpret CAD (e.g. Solidworks) drawings is required.
Strong technical written, verbal, analytical and interpersonal skills. Self-motivated. Strong time management and organizational skills.
Strong statistical skills (e.g. ANOVA, distribution analysis, DOE, significance tests, process capability, sampling plans, regression, GR&R, etc.).
Demonstrated experience using Microsoft Office products, Outlook and Minitab.
American Society for Quality, Certified Quality Engineer (CQE) preferred.
Six Sigma Black Belt and Lean Methods certification is a plus.
Experience in managing a Quality Assurance team is a plus.
Demonstrated mastery of Quality Assurance and Quality Engineering principles.
Demonstrated proficiency in theory and practical application of ‘Geometric Dimensioning & Tolerancing’ (GD&T)
Demonstrated proficiency with Six Sigma process tools such as ‘Define, Measure, Analyze, Improve, Control’ (DMAIC), ‘Failure Modes & Effects Analysis’ (FMEA), ‘Design of Experiments’ (DOE), Gage Repeatability & Reproducibility’ (Gage R&R) and ‘Statistical Process Control’ (SPC)
Demonstrated interpersonal, communication and presentation skills. Must be comfortable presenting at senior management level meetings
Strong interpersonal, communication, influencing and presentation skills essential.
Demonstrated leadership, project management and engineering experience in Quality Assurance in a regulated environment preferred.
Flexibility essential with strong project management skills.
Requires an analytical, logical and strategic thought process. Experience of GD&T, process mapping, statistical methods and process/ product validations would prove beneficial.
Demonstrated proficiency in MS Office (including MS Word, MS Excel, MS PowerPoint, MS Access) and MS Outlook.
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