Systems Manager - Quality

Rockline Industries, Inc; Sheboygan (WI); On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

Medical, dental, vision coverage

Wellness programs

Retirement plan with company match

Paid time off starting on day one

Employee discounts

Job summary

Rockline Industries in Sheboygan, Wisconsin, seeks a Quality Systems Leader to oversee CAPA, change management, customer complaints, product release, internal audits, and document control in a FDA-regulated manufacturing environment.

You will lead deviation and non-conformance programs, drive regulatory readiness, coordinate annual product reviews, manage audits, and mentor a quality team while upholding Rockline's RRITE values.

Qualifications

• Bachelor's degree in Chemistry, Microbiology, Biology, Engineering, or related scientific field.
• Minimum of seven years supporting quality assurance systems in FDA-regulated environments.
• Minimum of three years in leadership or advisory roles.
• Five+ years interacting with regulatory agencies such as FDA or TGA.

Responsibilities

• Develop and manage deviation, non-conformance, investigation, and CAPA processes.
• Lead the site's Change Management program and document control activities.
• Oversee customer complaint investigations, trend analysis, reporting, and corrective actions.
• Manage product release, batch record reviews, quality metrics, and CoAs.
• Coordinate Annual Product Reviews and Quarterly Management Reviews.
• Lead Internal Auditing, auditor training, and reporting.
• Drive GMP, sanitation programs, and continuous improvement across the facility.
• Coach and manage direct reports and promote Rockline RRITE values.

Skills

Root cause analysis

Risk analysis

CAPA management

Regulatory investigations

Internal & external audits

Document control

Change management

Complaint management

Deviation & non-conformance

Education

Bachelor's degree in Chemistry / Microbiology / Biology / Engineering

Job description

Job Category: Quarterly Check-in (Manager with Qtrly DRs)

Requisition Number: SYSTE007323

• Posted : July 29, 2026
• Full-Time
• On-site

Locations

Showing 1 location

As a key member of the Quality team, you will oversee core quality system processes including CAPA, change management, customer complaints, product release, internal auditing, document control, and regulatory readiness. You will play an important role in ensuring compliance with FDA regulations, customer requirements, and internal quality standards while helping drive continuous improvement across the facility.

Quality Systems Leadership

• Develop and manage deviation, non-conformance, investigation, and CAPA processes.
• Lead and maintain the site's Change Management program.
• Oversee customer complaint management, including investigations, trend analysis, reporting, and corrective actions.
• Manage product release activities, batch record review processes, quality metrics, and customer Certificates of Analysis (CoAs).
• Coordinate Annual Product Reviews and Quarterly Management Reviews.
• Administer the Document Control program, including change control activities and system metrics.
• Lead the Internal Auditing program, including auditor training, audit execution, system development, and reporting.

Regulatory Compliance & Continuous Improvement

• Partner closely with Quality Operations, Quality Laboratory, and Manufacturing teams to ensure effective and compliant quality systems.
• Serve as a key participant during FDA inspections, customer audits, and third-party regulatory audits.
• Manage GMP and sanitation programs and improvement initiatives.
• Drive a culture of quality, compliance, and operational excellence throughout the organization.
• Develop, coach, and manage direct reports.
• Foster collaboration and accountability while supporting Rockline's RRITE values of Renew, Respect, Integrity, Teamwork, and Excellence.

What We're Looking For

Required Qualifications

• Bachelor's degree in Chemistry, Microbiology, Biology, Engineering, or a related scientific discipline.
• Minimum of seven years of experience supporting quality assurance systems within pharmaceutical, medical device, or other FDA-regulated manufacturing environments.
• Minimum of three years of leadership experience or experience serving in an advisory capacity.
• Five or more years of experience interacting with regulatory agencies or regulatory bodies, such as the FDA or TGA.
• Demonstrated experience with:
• Root cause analysis
• Risk analysis methodologies
• CAPA management
• Regulatory investigations
• Internal and external audits
• Document control systems
• Change management
• Complaint management
• Deviation and non-conformance programs

Preferred Qualifications

• Advanced degree in a scientific or related discipline.

Why Join Rockline?

Rockline Industries is a privately held manufacturer and distributor of consumer packaged goods with a long-standing reputation for innovation, quality, and customer partnership. Our associates help produce products used by millions of consumers every day.

When you join Rockline, you\'ll find:

• A stable, privately held organization focused on long-term success
• Opportunities to make a meaningful impact in a highly regulated manufacturing environment
• Cross-functional collaboration with operations, quality, laboratory, and leadership teams
• A culture built around our RRITE values: Renew, Respect, Integrity, Teamwork, and Excellence
• Career growth and development opportunities within a global manufacturing organization

With headquarters in Sheboygan, Wisconsin, Rockline employs more than 800 associates locally and thousands globally, supporting customers and consumers across North America and beyond.

Benefits That Support You

We offer a comprehensive benefits package designed to support your health, financial security, and work-life balance, including:

• Medical, dental, and vision coverage
• Wellness programs
• Fitness reimbursement
• Retirement savings plan with company match
• Life and disability insurance
• Optional supplemental coverage
• Paid time off starting on your first day
• Employee discount programs

Mental Health Support

• Confidential counseling and resources for personal and work-life needs

FLSA Status: Exempt

Qualifications

Skills

Behaviors

:

Motivations

:

Education

Experience

Licenses & Certifications

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
This employer is required to notify all applicants of their rights pursuant to federal employment laws.For further information, please review the Know Your Rights notice from the Department of Labor.