Senior Quality Systems SpecialistLocation: Cary, Illinois
About Our Client:
Our client has built a high-trust, people-first culture driven by real employee feedback and a commitment to innovation, collaboration, and performance. Known for fostering an environment where employees feel valued, supported, and empowered to grow, the organization continues to set itself apart as an employer of choice. Working here means joining a team of top technical professionals bringing cutting-edge products to the forefrontoffering driven individuals the opportunity to make a meaningful impact every day.
Key Responsibilities:- Owning and managing the Change Control process ensures compliance, consistency, and effectiveness.
- Reviewing and approving change records promotes completeness, accuracy, and appropriate impact assessments.
- Ensuring changes are implemented appropriately includes verifying downstream activities such as documentation updates, training completion, and record retention.
- Driving process improvements and standardization supports integration efforts across departments.
- Evaluating process gaps helps in defining compliant, scalable solutions.
- Collaborating with cross-functional teams aligns change activities with integration timelines and business needs.
- Mentoring and guiding change owners and stakeholders on proper change control processes enhances overall compliance.
- Providing coaching on impact assessment, documentation expectations, and process requirements improves execution quality.
- Promoting consistent and high-quality execution of change activities ensures organizational standards are met.
- Developing and revising quality system documentation, including procedures, work instructions, and change records, maintains system integrity.
- Ensuring documentation is clear, accurate, and compliant supports internal and regulatory requirements.
- Partnering with Quality, Regulatory, R&D, and Operations teams facilitates alignment on changes and integration efforts.
- Acting as a quality representative in project discussions and integration activities strengthens compliance oversight.
- Communicating progress, risks, and recommendations to key stakeholders keeps all parties informed and engaged.
Qualifications: - Bachelors degree in engineering, science, or a related field.
- 5+ years of experience in a regulated environment (medical device preferred).
- Proven experience with Change Control processes and quality system integration or harmonization.
- Strong knowledge of Quality Management Systems (QMS) and applicable regulatory requirements (e.g., FDA, ISO 13485, EU MDR).
- Deep understanding of interactions between Change Control, Document Control, Training, and Records processes.
- Excellent technical writing and documentation skills.
- Strong organizational, problem-solving, and project coordination abilities.
- Ability to influence, mentor, and drive consistent process execution across cross-functional teams.
- Ability to manage multiple priorities in a fast-paced, integration-focused environment.
- Strong attention to detail and commitment to quality and compliance.
- Collaborative mindset with a proactive, solution-oriented approach.
- Proficiency in Microsoft Office applications, including Word, Excel, PowerPoint, Teams, and SharePoint.
- Fluency in English (written and verbal).
- Ability to work flexible hours to accommodate German time zones.
- NO C2C CANDIDATES
Interested Candidates please apply on our website at https://jobs.jblresources.com.
For more information about our services and great opportunities at JBL Resources, please visit our website: https://www.jblresources.com.
JBL Resources is proud to have earned the reputation of being a premier provider of top talent professionals in the fields of engineering, human resources, logistics, operations, and supply chain management. As specialists in both permanent placement and contract services, our mission is to help companies and individuals become all they were created to be.
**JBL is an Equal Opportunity Employer and E-Verify Company