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
Stryker is hiring a Staff Quality Engineer in Ventura, CA.
Stryker Ventura manufactures patient-fitted prostheses for the reconstruction of the temporomandibular joint. Each prosthesis is individually fabricated for the unique anatomy of the patient. Most of our patients have had more than 5 previous surgeries resulting in significant bone loss and distortion to the normal anatomical features. The patient-specific total joint is a PMA approved (US) and custom made (OUS). The Stryker Ventura site has in-house EtO sterilization and over 20+ years of clinical history.
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
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
What you will do:
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.
Support the maintenance of the Stryker Ventura Quality System to meet the requirements of ISO 13485:2016, MDSAP and EU Medical Device Regulation
Work closely with the design and development as well as the business functions to ensure quality performance of product and processes.
Act as interface function between quality, R&D, regulatory, and manufacturing and support the process development in the division and with other Stryker locations.
Support new product development and maintenance projects for CMF with quality expertise to make sure that procedures and regulations are met.
Participate in design reviews and document level reviews of design documentation.
Own identified internal and design-related 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.
Engage in the determination of critical characteristics and risk management activities.
Support critical assessment of internal and supplier proposed change management activities.
Participates and may lead in the creation and/or review of new or modified procedures.
Maintain Division 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 design related complaints and product field actions.
Support and Drive Human Factor practices, familiarity in the science of Human Factor identification, reduction, and mitigation.
Develop understanding of risk management practices and concepts and applies knowledge to risk management file creation and upkeeping.
Applies statistical methods of analysis.
Engage and interface in internal and external audits providing subject matter expertise.
Support the development and review of product validation/qualification and MSA of internal processes.
Execute internal quality deliverables associated with engineering changes, design transfers and design activities.
Drive continuous improvement actions to improve product quality.
Provide leadership and subject matter expertise in Design Quality Assurance activities to the overall site.
What you will need:
BS in a science, engineering, or related discipline.
4+ years' experience preferred.
Knowledge of Risk Management, Validation Programs and Design Controls in a highly regulated environment
Ability to think critically, solve complex problems, and work on large cross-functional and diverse teams.
5+ years of experience preferred in New Product Development (NPD)
MS, CQE, or CRE preferred.
Six Sigma Green or Black belt preferred.
Previous med device industry and/or manufacturing experience in a highly regulated environment
Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.) desired.
Understanding of US and International Medical Device Regulations.
Stryker is one of the world's leading medical technology companies and, together with our customers, we are driven to make healthcare better. The Company offers a diverse array of innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. Stryker is active in over 100 countries around the world.
Together with our customers, we are driven to make healthcare better.
At Stryker, quality is first in everything we do. We are driven to make healthcare better for our customers by
providing innovative products and services that meet regulatory requirements through our effective quality system.
The Company was founded in 1941 by Dr. Homer Stryker and incorporated in 1946 as the Orthopedic Frame Company. In 1964, the Company’s name was changed to Stryker Corporation.
• $13.6 billion in annual sales in 2018; annual revenue has grown for 39 straight years
• 17.1% CAGR (compound annual growth rate) in sales over 39 years
• ~36,000 employees globally in 2018
• 43 manufacturing and research & development locat...ions worldwide
• Included in the Standard & Poor’s 500 Index
• Ranked # 233 on Fortune Magazine’s “FORTUNE 500” list for 2019
• Ranked # 3 on Fortune Magazine’s “World’s Most Admired Companies” list for the “Medical Equipment” industry for 2019
• Ranked # 11 on Fortune Magazine’s “100 Best Companies to Work For” list (U.S.) for 2019
• Spent $862 million on R&D in 2018
• 7,784 patents owned globally in 2018
• Initial public offering of stock was in 1979
• Listed on the New York Stock Exchange under ticker SYK