Quality Systems Engineer; Hybrid

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.

• 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.

• 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.