Quality Assurance Manager

RRD; Cudahy (WI); On-site; USD 90,000 - 120,000; Full time

Job summary

RRD is seeking a Quality Assurance Manager to oversee and advance our quality systems and standards! The role focuses on implementing and maintaining a robust QMS, metrics, and continuous improvement across the site.

The successful candidate will lead the quality team and drive CAPA, audits, and regulatory alignment to ensure compliant, quality products. Strong collaboration with management and operations is essential, with emphasis on customer-facing quality responses and adherence to ISO 9001

Qualifications

• Minimum 4-year Bachelor's Degree in a related field.
• 5+ years related work experience with at least 2 years supervisory experience.
• Advanced training or experience in cGMPs and ISO requirements.

Responsibilities

• Lead and improve the site Quality Management System and Quality Metrics.
• Coordinate annual certification audits and GMP/regulatory compliance.
• Perform root cause analysis and drive CAPA closure.
• Monitor QMS processes and report metrics to leadership.
• Support customer inquiries and RFP/RFI responses related to quality.
• Oversee deviation investigations and document findings.
• Lead quality department personnel and provide direction.

Skills

Quality Mgmt

GxP Knowledge

Leadership

Auditing

Regulatory Knowledge

Education

Bachelor's Degree in Related Field

Tools

MS Office

Job description

RRD provides marketing, packaging, print, and business services to the world’s most respected brands. The company’s proprietary technology, advanced data analytics, and expertise fuel organizational decision-making from strategy through execution, delivering sustainable solutions with the lowest possible environmental impact. Global organizations and regulated industries trust RRD to reduce complexity and drive audience connections across the entire customer journey.

Job Description

RRD is seeking a Quality Assurance Manager to oversee and advance our quality systems and standards!

Job Summary

The Quality Manager will oversee the implementation, maintenance and continuous improvement of the site Quality Management System and Quality Metrics performance. He/She will work with site management and personnel to plan, develop, implement and continually improve site relevant QMS requirements, and to ensure sustainable compliance to customer, regulatory and RR Donnelley QMS requirements.

Responsibilities

• Provides ongoing leadership and support in maintaining and continually improving of site Quality Management System (QMS) and processes inclusive of food safety / contact & Medical Device / Pharma GMP’s, as required.
• Ensures that site QMS is in compliance with RRD QMS requirements, including Quality Task Tracker and Quality Metrics reporting.
• Coordinates activities to maintain relevant Quality System requirements such as ISO 9001:2008, GMP (21 CFR Part 820), etc., including preparing for and scheduling annual certification compliance audits.
• Informs site Management of significant or potentially significant quality issues, and facilitates effective root cause analysis and corrective/preventive actions to reduce or eliminate errors.
• Monitors and measures trends in QMS processes, including GMP Quality Metrics.
• Evaluates the effectiveness of relevant site QMS processes (such as ISO 9001:2008, GMP (21 CFR Part 820)) through internal audits and the evaluation of site Quality Metrics data.
• Collects and submits quality task tracker and quality metrics data for the site, on a monthly basis, and issues a report to the Platform Quality Lead
• Interacts with customers and assists with quality related responses to RFP’s/RFI’s for the site.
• Reviews relevant GMP documents for compliance to company SOPs, quality systems, and regulatory requirements.
• Leads and manages ongoing internal process verification audits throughout year.
• Provides leadership and direction to quality department employees.
• Ensures all deviation investigations are appropriately investigated and recorded.
• Drives CAPA items to complete and timely completion.
• Participates in other activities, as deemed appropriate.

Qualifications

• Minimum: 4 Year / Bachelors Degree in Related Field
• Minimum 5+ years related work experience including a minimum of 2 years of supervisory experience.
• Advanced training or experience in cGMPs, and ISO required.
• Ability to understand and interpret federal regulations and company operating procedures as they apply to printing regulated product and quality issue..
• Must be able to prioritize and multi-task with minimal supervision.
• Knowledge of PC systems and Microsoft Office Suite (Word, Excel) required.
• Excellent written and verbal communication skills.

Additional Information

RRD is an Equal Opportunity Employer, including disability/veterans

At RRD, we value innovation, authenticity, and integrity. To uphold the security and fairness of our hiring process, we ask that candidates refrain from using AI tools during interviews to ensure an authentic and secure experience. We appreciate your cooperation as we work to maintain a transparent and equitable hiring process.

All employment offers are contingent upon the successful completion of both a pre-employment background and drug screen.