Rockline Industries, people who make it right · 1 week ago
Quality Manager III
Morristown, TN
Full-time
Onsite
Senior Level, Lead/Staff
10+ years expIatric Manufacturing Solutions is dedicated to fostering healthier environments by producing FDA-regulated wipes for various industries. As a Quality Manager III, you will lead the Quality Assurance function, ensuring products meet regulatory standards and overseeing multiple quality teams to drive compliance and continuous improvement.
ConsumerConsumer GoodsHealth CareManufacturing
Responsibilities
Lead and develop Quality teams through hiring, training, and performance management
Ensure compliance with FDA regulations (21 CFR Parts 210, 211, 820), ISO standards, and global requirements
Oversee Quality Management System (QMS) and strategic quality initiatives
Manage batch record reviews, validation reporting, NC/CAPA investigations, and change control activities
Drive process improvements, validation activities, and new product commercialization
Build strong relationships with customers and suppliers to resolve quality issues and support new product launches
Lead internal and external audits and implement corrective actions
Qualification
Required
Bachelor's degree in Science, Engineering, or related technical discipline
Minimum 10 years in Quality Assurance Management within an FDA cGMP-regulated manufacturing environment
Strong knowledge of 21 CFR compliance, cGMP, ISO 13485, HACCP/FMEA, auditing, risk management, SPC, DOE, and validation processes
Proven leadership in Quality Engineering and Quality Control
Preferred
Pharmaceutical/OTC Drug/Medical Device experience preferred
ASQ Certified Quality Auditor/Engineer, Certified Pharmaceutical cGMP Professional, or Regulatory Affairs Professional Certification (RAPS)
Benefits
Medical, dental, vision coverage, wellness programs, and fitness reimbursement
Retirement savings with company match, life and disability insurance, and optional supplemental coverage
Paid time off, education reimbursement, and employee discount programs
Confidential counseling and resources for personal and work-life needs
Company
Rockline Industries, people who make it right
Rockline Industries was founded in 1976 and is headquartered in Sheboygan, Wisconsin.
1001-5000 employees
H1B Sponsorship
Rockline Industries, people who make it right has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (2)
2022 (5)
2020 (1)
Funding
Current Stage
Late StageLeadership Team
Jane Fischer, PHR, SHRM CP
Human Resources Business Partner
Rebecca Williams-Lencho, SCP, MJ-LEL
Human Resources Business Partner
Recent News
BizTimes Milwaukee
2025-06-26
2025-06-25
Company data provided by crunchbase