As a Staff Quality Systems Specialist, you will be primarily responsible for the development of the quality management system (QMS) in accordance with relevant regulatory requirements. Oversee, support, and ensure that an effective and efficient QMS is built and maintained. Responsibility for ensuring that all applicable quality system regulations are met to receive regulatory clearance/certification. Facilitates proactive and effective resolution of issues through expertise in problem-solving methodology.

Workplace Flexibility: Hybrid work schedule with three onsite days (Monday, Tuesday, and Wednesday) and the option to work remotely on Thursday and Friday. Candidates must reside within a reasonable commuting distance of Cary, IL to support regular onsite collaboration and business needs.

What you will do:

• Support the maintenance, compliance, and continuous improvement of the Quality Management System (QMS) to ensure alignment with internal procedures, regulatory requirements, and business objectives.

• Identify, recommend, and implement process improvements that enhance the effectiveness, efficiency, and scalability of quality system processes.

• Partner cross-functionally to develop, revise, and maintain quality system policies, procedures, and documentation that support operational and new product development activities.

• Coordinate QMS activities and quality initiatives to support business priorities, project milestones, and organizational objectives.

• Monitor and analyze quality system metrics, key performance indicators (KPIs), and process performance data to identify improvement opportunities and drive action plans.

• Provide training, guidance, and subject matter expertise on QMS processes, compliance requirements, and quality best practices.

• Support internal, corporate, and external audit activities, including audit preparation, participation, response coordination, and follow-up actions.

• Promote compliance with applicable quality standards and regulations, including FDA, ISO 13485, MDR, GMP, GDP, and other relevant requirements.

What you will need:

Required:

• Bachelor’s Degree in a Science, engineering, business or related discipline

• Minimum of 4 years of experience supporting Quality Systems within a regulated industry (e.g., medical device, pharmaceutical, biotechnology, cosmetics, manufacturing, aerospace, or other regulated environments).

• Experience developing, implementing, maintaining, and/or continuously improving Quality Management System (QMS) processes, procedures, and documentation.

• Working knowledge of core Quality Systems elements such as document control, change management, risk management, validation, and/or Corrective Action Preventative Actions (CAPA) .

Preferred:

• Proficiency in statistical analysis methods and the application of data-driven decision-making tools.

• Experience utilizing structured problem-solving and continuous improvement methodologies (e.g., process mapping, benchmarking, root cause analysis, fishbone diagrams, tree diagrams).

• Demonstrated experience identifying process improvement opportunities and leading initiatives from assessment through implementation.

• Experience driving operational, quality, or compliance-related efficiency improvements within a regulated environment.

$91,600 - $152,700 USD Annual

Travel Percentage: 10%