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.
Working in partnership with the Global Supplier Network, you'll be involved in the ongoing support for the internal business units to address ongoing OEM/CM quality issues, development of suppliers and ensuring that our external supply chain is capable of meeting expectations from a quality, service and cost perspective. You will serve as liaison between OEM/CM's and Stryker to drive effective continuous improvement as a result of the supplier base. You will work with internal customers and suppliers in support of supplier quality issues; provide technical support for activities related to supplier quality system assessment and performance evaluation.
You will collaborate with the strategic sourcing, auditing and development groups to understand the capabilities and competencies of OEM/CM's to meet our requirements and continually meet and adapt to our product quality and regulatory requirements.
This role will provide coaching and guidance to the OEM/CM team to ensure compliance to technical, regulatory and Stryker requirements.
Key Areas of Responsibility
Act as liaison for customer groups on key compliance issues
Provides leadership to the OEM/CM Team being responsible for the plant metric reporting and local SME for OEM/CM Quality procedures & processes
Ownership and reporting on all quality issues associated with OEM/CM suppliers within the assigned commodity. Ensure all Supplier related material quality issues are effectively communicated.
Oversight of the OEM/CM material related processes which include: Material Review Board to ensure Coordination of MRB activities with the business unit to ensure the timely assessment of potential non-conforming products.
Act as a point of Contact for OEM/CM Quality during External Audits and Internal Audits as required.
Ensure Regulatory compliance in area of responsibility to GMP of all medical device's regulatory agencies (i.e. FDA, IMB, Notified bodies, etc)
Develop structured communication channels with strategic sourcing, identifying responsibility by OEM/CM.
Liaising with the Manufacturing and Quality groups and Business Units, in assessing and addressing material quality issues.
Track OEM/CM quality performance measurement (KPI's) and participate in supplier performance reviews. Enable reporting of metrics for monthly reviews and represent the OEM/CM quality team at the Monthly Business Review.
Oversight of the Approved Supplier List (ASL) in conjunction with the Procurement function
Drive continuous improvement activities focusing on OEM/CM quality.
Professional Requirements- Required:
Honors Bachelor's Degree in Engineering or Science fields or equivalency.
Minimum of 4 years' experience in manufacturing environment.
Good knowledge with GMP, ISO 13485, 21 CFR Part 820 standards
Working knowledge of FMEA, Validation Programs and SPC processes in a highly regulated environment
Good knowledge of lean tools and concepts. Demonstrated the ability to apply lean concepts throughout a manufacturing operation to improve quality
Demonstrated working knowledge to influence positively the trend of the relevant supplier quality metrics.
Strong analytical and problem-solving capabilities with the ability to draw insights from data quickly and to define executable actions
Ability to plan, organize and implement multiple concurrent tasks
Strong communication skills. Must demonstrate the ability to communicate up/down and across different levels of the organization.
Demonstrated ability to work in cross-functional team environments
Willing to travel in support of business needs to different geographical locations.
Professional Requirements- Desirable:
Lead Quality Auditor Qualification either in AS 9100 or ISO13485, CFR820 or comparable industry standards and regulatory requirements
ASQ CQE/CQM/PE certification
Strong project management capabilities with the capacity to leverage and apply knowledge
Must be able to represent & guide the OEM/CM quality teams
Must enjoy working in team environment and undertaking leadership tasks
Must demonstrate outstanding collaboration and communication skills.
Highly motivated and able to build close relationships internally and externally.
Demonstrated ability for conflict resolution and constructive competence
Must demonstrate multitasking skills as this individual will be responsible for multiple tasks at the same time.
The individual should enjoy working in a dynamic and results oriented team environment focusing on quality, compliance and customer satisfaction
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