Quality System Manager at Insight Global Quality System Manager at Insight Global in Ft Mitchell, Kentucky Posted in 6 days ago.
Type:
full-time
Job Description:
Quality System Manager Job Opportunity (DIRECT HIRE)
Location :
Fully onsite in Florence, KY (RELOCATION
PACKAGE OFFERED
)
Shift:
1st Shift (M-F)
Compensation:
$140,000/yr
- $155,000/yr
- per annual salary Exact compensation may vary based on several factors, including skills, experience, and education. Benefit packages for this role may include healthcare insurance offerings and paid leave as provided by applicable law. Required Skills & Experience
- 8+ years of experience in Quality Systems, Quality Engineering, or Quality Leadership roles within manufacturing environments
- Hands-on experience preparing sites for and supporting ISO certification and external audits
- Experience designing and implementing processes/systems
- Exposure to regulated environments (FDA, chemical industry)
- Strong FMEA and problem?solving experience
- Experience with ISO 9001 and/or
ISO 14001
- Comfortable communicating up and down the organization
- Hands?on, systems?focused, and able to drive change Nice to Have Skills & Experience
- 13485 experience
- Auditing experience Job Description We are seeking a seasoned Quality Systems Leader to build, standardize, and stabilize quality operations across both a manufacturing site and its supporting laboratory environment.
This is a transformation-focused leadership role, ideal for someone who has successfully implemented quality systems from the ground up and driven measurable operational improvement. This is not a maintenance role-the site is evolving from a startup environment into a more mature, scalable operation and requires a leader who can establish structure, drive change, and elevate overall quality performance. Key Responsibilities Quality Systems & Governance Design, implement, and standardize end-to-end Quality Management Systems (QMS) aligned to ISO standards Establish structured processes across manufacturing and laboratory functions, ensuring consistency and scalability Lead efforts to prepare the site for ISO certification and external audit readiness Validation & Compliance Own and oversee all validation activities, including:
IQ/OQ/PQ
Process validation Cleaning validation Software/systems validation Strengthen validation rigor and ensure compliance with regulated environments (FDA, chemical industry standards) Operational Excellence & Continuous Improvement Drive Lean Quality and Continuous Improvement (CI) initiatives to reduce waste, improve cycle times, and optimize working capital
Improve:
Test analysis timelines Product qualification processes Validation efficiency Introduce structured problem-solving methodologies (e.g., root cause analysis, data-driven decision-making) Problem Solving & Quality Performance Lead and facilitate root cause investigations, CAPAs, and change control processes Address ongoing quality issues through data-driven diagnostics and corrective actions Improve overall process reliability, repeatability, and performance Laboratory Leadership Oversee laboratory operations, including staffing, workflows, and process efficiency Assess current capabilities and implement improvements to increase throughput and reduce turnaround times Align lab operations with broader quality and manufacturing objectives Cross-Functional Partnership Partner closely with Manufacturing to improve process stability and product quality Benchmark sister sites and implement best practices and standardized processes locally Serve as the site-wide quality leader, influencing stakeholders at all levels Coaching & Change Leadership Build a continuous improvement mindset across the workforce Coach and upskill teams on: Structured problem-solving Data analysis and interpretation Quality best practices Lead organizational change as the site transitions to a more mature operating model
