Senior Quality Engineer, New Products Introduction
Internal Number: R456505
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 the #5 World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine. Learn more about our award-winning organization by visiting stryker.com
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.
Responsible for the identification of potential failure modes and risks, and the development of quality assurance practices and controls in multiple new product developments and/or manufacturing transfers. Knows and applies the fundamental and some advanced concepts, practices and procedures of the new product introduction quality specialization.
Support the required stages defined in the product and process design cycle ensuring compliance with the current design control and transfer regulations and policy.
Responsible for the evaluation of process risks, risk mitigation and ensures appropriate production and process controls are identified, qualified and implemented throughout the product manufacturing lifecycle (from incoming of materials/components, manufacturing, until product release).
Implement internal detective process controls.
Specify which preventative and detective controls are required, and communicate to vendors, internal/ external clients.
Verify gage repeatability, reproducibility, and accuracy, and address deficiencies on inspection methods
Support the development of inspection methods.
Validate inspection methods and ensure methods between supplier and Stryker correlate accordingly.
Ensure potential process failures are reproduced and/or tested to evaluate internal and external impact.
Support the identification of new suppliers and supplier development activities to ensure compliance and business continuity.
Lead supplier component qualifications through Production Part Approval Process (PPAP) and ensure appropriate controls are placed at the suppliers to ensure and verify components quality.
Collaborates with Staff Engineer in all process validation activities to ensure consistent, repeatable and effective processes are implemented during design/manufacturing transfer.
Develop a validation strategy.
Develop statistical rationale for testing.
Develop the rationale for validation sample size, duration, and number of runs.
Ensure worst-case scenarios are challenged during the process development and/or validation.
Eliminate waste from the processes (i.e. scrap, rework, wait times, etc).
Execute performance qualification activities for new process.
Develops sterilization validation strategies with Subject Matter Experts and is responsible to execute and document such validation activities.
Continuously fully comply with all quality regulatory requirements.
May support internal and external audits.
Commit to environmental policy.
May train others in quality assurance/GMP related topics.
Prepare product and operations for transition, by training quality assurance engineers and inspectors and conducting knowledge transfer activities.
Lead quality activities during Post Launch Monitoring
Measure, Analyze and report key process indicators.
Develop the quality report and communicate product/process performance to the Operation Unit assigned for new products.
Stop further processing in the event of encountering non-conforming product condition.
Lead investigation and on-time closure of non-conformances, corrective & preventive actions internally and at suppliers.
Has some latitude for unrelieved action or decisions.
Works with minimum supervision, conferring with superiors on unusual matters.
Viewed as a team resource in the area of expertise (i.e. Inspection Methods, Quality System, Design Transfer, Process Validations, Sterilization, PPAP, Risk Management, Applied Statistics...) and develops/trains other engineers in this area.
Provides coaching to Engineers, Coops and/or Contractors.
Customer Service Orientation: Keeps customer (internal and external) needs in mind when approaching all tasks and decisions.
Collaborative Teamwork: Works effectively with others to achieve team and organizational goals.
Individual Influence: Influences others of the merits of own point of view and earns their support. Possesses personal credibility and inspires confidence, handles opposition constructively, and treats others with respect.
Promotes clear communication of project quality expectations to team members, divisional contacts and suppliers.
Engagement: Encourages, inspires, and influence others, creating a positive impact on the team, builds an engaged employee team in pursuit of the shared vision.
May coordinate the activities of one or more Quality Control Inspectors and/or technicians.
May evaluate the performance of one or more Q.C. inspectors and/or technicians based on pre-established performance parameters.
Sedentary Work: Exerting up to 10 lbs. of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, etc. Generally involves sitting most of the time.
Very good visual acuity.
The ability to work with and inspect very small objects and/or tools and component parts.
May involve prolonged periods of stooping, kneeling, crouching, bending, sitting, standing, and/or crawling as appropriate.
Coordination of eye, hand, and/or foot movement with an ability to grasp by hand and meet cognitive demands to include visual and auditory discrimination/memory, reading ability, and memory retention ability.
Requires use of safety glasses in designated areas.
Closed-toe shoes must be worn on the production floor; safety shoes are recommended.
Must be able to observe and note minute inconsistencies.
Must be able to generate, follow, and explain detailed instructions and inspection procedures.
Must be able to complete detailed documentation accurately.
Must be able to communicate product and/or component part deficiencies to Engineer, subordinate, or supervisory personnel.
Must be able to analyze and resolve non-routine product issues using independent judgment and inspection equipment.
Excellent interpersonal communication, collaborative team work, and negotiation skills.
Blueprint/engineering schematic reading and interpretation.
Must be able to analyze and correct complex process and/or system issues of a broad scope using independent judgment.
Basic inspection techniques.
Basic PC skills.
Excellent written/oral communication skills.
Demonstrated ability to operate small hand tools (e.g. pliers, screwdrivers, hammer, wrenches, etc.), power tools and test/inspection equipment.
Demonstrated mechanical/electrical troubleshooting and problem solving skills.
Strong knowledge in Validation per FDA-QSR and ISO guidelines.
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