Staff Quality Systems Engineer (Hybrid)

Cary, MS - USA

Monthly Salary: Not Disclosed

Posted on: 05-11-2025

Vacancies: 1 Vacancy

Job Summary

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.

What you need

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.

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.

Travel Percentage: 10%

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race ethnicity color religion sex gender identity sexual orientation national origin disability or protected veteran status. Stryker is an EO employer M/F/Veteran/Disability.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about discussed or disclosed their own pay or the pay of another employee or applicant. However employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information unless the disclosure is (a) in response to a formal complaint or charge (b) in furtherance of an investigation proceeding hearing or action including an investigation conducted by the employer or (c) consistent with the contractors legal duty to furnish information.

Required Experience:

Staff IC

Work Flexibility: HybridStryker 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-fu...

Work Flexibility: 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.

What you need

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.

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.

Travel Percentage: 10%

Required Experience:

Staff IC

Key Skills

Computer Science
Docker
Kubernetes
Python
VMware
C/C++
Go
System Architecture
gRPC
OS Kernels
Perl
Distributed Systems

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About Company

Stryker

Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongsid ... View more

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