Quality Systems Manager – FDA-Regulated Manufacturing

Rockline Industries, people who make it right; Sheboygan (WI); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Wellness programs

Retirement plan

Life insurance

Paid time off

Education reimbursement

Employee discounts

Mental health support

Job summary

Rockline Industries, headquartered in Sheboygan, Wisconsin, seeks a seasoned Quality Systems Leader to oversee CAPA, change management, customer complaints, product release, audits, and document control to ensure FDA regulatory readiness.

The role emphasizes driving continuous improvement, leading a team, and coordinating annual product reviews alongside cross-functional stakeholders to uphold Rockline's RRITE values of Renew, Respect, Integrity, Teamwork, and Excellence.

Qualifications

• Bachelor's degree in a scientific discipline required.
• Minimum 7 years supporting QA systems in FDA-regulated environments.
• Minimum 3 years in a leadership or advisory role.
• 5+ years interacting with regulatory agencies such as FDA or TGA.

Responsibilities

• Oversee CAPA, change management, and complaint management within the quality system.
• Manage product release, batch review, and CoA processes; track quality metrics.
• Coordinate annual product reviews and quarterly management reviews.
• Lead the internal auditing program including training, execution, and reporting.
• Drive regulatory readiness and ensure GMP compliance across the facility.

Skills

Root cause analysis

Risk analysis

CAPA management

Regulatory investigations

Internal audits

Document control

Change management

Complaint handling

Deviation handling

Non-conformance control

Education

Bachelor's degree in Chemistry, Microbiology, Biology, Engineering, or related

Job description

Rockline Industries, headquartered in Sheboygan, Wisconsin, seeks a seasoned Quality Systems Leader to oversee CAPA, change management, customer complaints, product release, audits, and document control to ensure FDA regulatory readiness.

The role emphasizes driving continuous improvement, leading a team, and coordinating annual product reviews alongside cross-functional stakeholders to uphold Rockline's RRITE values of Renew, Respect, Integrity, Teamwork, and Excellence.