Staff Quality Systems Engineer (Hybrid)

Stryker • Cary, IL

14d • Hybrid

About The Position

Work Flexibility: Hybrid Stryker is hiring a Staff Quality Systems Engineer, (Hybrid) to join the team in Cary, IL . This is a hybrid role, and candidates must live within a reasonable commuting distance to the site. The role is highly visible and requires strong engagement across leadership and cross-functional teams. What you will do Strong knowledge of Quality concepts (CAPA, risk management, validation, statistics, design controls, change management, etc.) 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.

Requirements

• 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 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.

Nice To Haves

• Experience in compliance risk situations, 510(k), Class I & II.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees