Stryker ยท 8 hours ago
Staff Quality Systems Engineer (Hybrid)
Cary, IL
Full-time
Hybrid
Senior Level, Lead/Staff
5+ years expStryker is hiring a Staff Quality Systems Engineer to join the team in Cary, IL. The role is highly visible and requires strong engagement across leadership and cross-functional teams, focusing on quality concepts and continuous improvement in quality management systems.
BiotechnologyHealth CareLife ScienceMedicalMedical Device
Responsibilities
Partner with, and coach, NC and CAPA teams in the application of problem-solving techniques (e.g. human error reduction, 4-D, etc)
Liaise with relevant functional groups, facilitating and mentoring teams through all stages of the NC/CAPA process by leveraging a high level of expertise in problem-solving, root-causing, risk management and statistical methods
Experience in root cause and failure analysis
Ability to conduct and document technical investigations
Identify and lead continuous improvement and collaboration opportunities, promoting development and implementation of opportunities to increase the compliance, efficiency, and effectiveness of the QMS
Assemble project teams, assign individual responsibilities, identify appropriate resources needed, and develop schedules to ensure timely completion of projects
Ensure QMS reflects actual activities, business needs and supports NPD requirements
Lead and coordinate preparation, participation and follow-up for Stryker internal, Corporate, and third-party audit activities
Qualification
Required
BS in a science, engineering or related discipline
5 years of experience in manufacturing, CAPA, quality systems, engineering, or equivalent required
Strong knowledge of Quality Systems (CAPA, audits, Management Review, Quality Planning, etc.)
Experience in a regulated environment and interaction with regulatory agencies
Experience performing and managing external audits by Notified Bodies, Regulators, or other Agencies / Accreditors
Thorough knowledge and understanding of US and international medical device regulations, EUMDR
Strong knowledge of Quality concepts (CAPA, risk management, validation, statistics, design controls, change management, etc.)
Experience in root cause and failure analysis
Ability to conduct and document technical investigations
Identify and lead continuous improvement and collaboration opportunities, promoting development and implementation of opportunities to increase the compliance, efficiency, and effectiveness of the QMS
Assemble project teams, assign individual responsibilities, identify appropriate resources needed, and develop schedules to ensure timely completion of projects
Ensure QMS reflects actual activities, business needs and supports NPD requirements
Lead and coordinate preparation, participation and follow-up for Stryker internal, Corporate, and third-party audit activities
Preferred
Experience in compliance risk situations, 510(k), Class I & II
Strong interpersonal skills, written, oral communication and negotiations skills. Must demonstrate the ability to effectively communicate up/down and across different levels of the organization
Ability to plan, organize, and implement multiple concurrent tasks
Highly developed problem-solving skills with demonstrated successful resolution of project-level issues
High proficiency in statistical methods and application
Expertise in risk management practices and concepts
Benefits
Medical and prescription drug insurance
Dental insurance
Vision insurance
Critical illness insurance
Accident insurance
Hospital indemnity insurance
Personalized healthcare support
Wellbeing program
Tobacco cessation program
Health Savings Account (HSA)
Flexible Spending Accounts (FSAs)
401(k) plan
Employee Stock Purchase Plan (ESPP)
Basic life and AD&D insurance
Short-term disability insurance
Company
Stryker
Stryker is a medical technology company that offers products and services in orthopaedics.
10001+ employees
H1B Sponsorship
Stryker has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (82)
2024 (76)
2023 (63)
2022 (78)
2021 (57)
2020 (77)
Funding
Current Stage
Public CompanyTotal Funding
unknown1990-01-02IPO
Leadership Team
Kevin Lobo
Chief Executive Officer
Glenn S. Boehnlein
Chief Financial Officer and Vice President
Recent News
GlobeNewswire News Room
2025-02-11
Company data provided by crunchbase