Quality Systems Manager: CAPA, Audits & Compliance

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

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.