Quality Process Manager

Central Package & Display; Minneapolis (MN); On-site; USD 90,000 - 110,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) with company match

Health Savings Account

Flexible Spending Account

Life Insurance (basic & supplemental)

AD&D Insurance

Disability Insurance

On-site Fitness Center

Background check before employment

Drug screen

Job summary

Central Package seeks a Quality Process Manager to lead the development, implementation, and ongoing improvement of the QMS in alignment with ISO 13485 and global standards. You’ll partner with Operations and Engineering to embed quality into the product lifecycle and support audit readiness and inspections.

The role requires oversight of document control, CAPA, training, and governance to ensure robust, compliant processes.

Qualifications

• Bachelor’s degree or 4 years of equivalent work experience.
• 2 years of experience managing Quality Management Systems.
• Experience or understanding of ISO 13485.
• Ability to prioritize work and manage multiple tasks when needed.
• Consistently produce work that meets the customer’s requirements.
• Project management skills.
• Past quality assurance experience in a manufacturing environment strongly preferred.
• Microsoft Office proficiency (Outlook, Word, Excel, PowerPoint).
• Clear and effective verbal and written communication skills.

Responsibilities

• Audit leadership and regulatory readiness for customer audits.
• Internal audit program management and corrective actions.
• QMS compliance and continuous improvement per ISO 13485.
• CAPA and complaint management oversight with root cause analysis.
• Training and quality culture development for compliance.
• Process and product quality improvements using Lean and risk-based methods.
• Customer interface and supplier audits including NAFTA and Canadian export docs.
• Supplier quality integration and ASL reviews.
• Cross-functional collaboration to improve QMSs.
• Digital QMS systems management and data integrity.
• Management Review inputs and performance metrics.

Skills

Quality Management Systems

Project management

Communication

Lean & risk-based methodologies

Education

Bachelor's degree

ISO 13485 knowledge

Tools

MS Office

Job description

Overview

Central Package is a leading manufacturer of protective packaging for the medical device industry. Our customers view us as a trusted partner. Learn more at www.centralpackage.com.

Quality Process Manager Position Summary

The Quality Process Manager is responsible for the development, implementation, maintenance, and continuous improvement of the Quality Management System (QMS) in compliance with applicable regulatory requirements (ISO 13485, and other global standards). Key responsibilities include managing Document Control and CAPA functions, ensuring robust governance, timely execution, and effectiveness of quality system processes. The role partners cross‑functionally with Operation Managers and Spec Building to embed quality into all stages of the product lifecycle and to support audit readiness and inspection success. The compensation range for this role is $90,000-110,000 based on a candidate’s experience and proficiency levels.

Responsibilities

• Audit Leadership & Regulatory Readiness: Provide leadership oversight to customer audits, including preparation, execution, reporting, and closure of audit findings. Ensure sustained inspection of readiness and successful outcomes with customers.
• Internal Audit Program Management: Provide leadership oversight of the internal audit program, including auditor selection, training, audit scheduling, execution, and driving timely and effective corrective actions to strengthen the QMS.
• QMS Compliance & Continuous Improvement: Develop, maintain, and continuously improve a robust Quality Management System compliant with ISO 13485 and applicable global regulations.
• CAPA & Complaint Management Oversight: Lead CAPA facilitators and ensure effective management of customer complaints and internal CAPAs, including root cause analysis, corrective/preventive actions, effectiveness checks, and trend analysis.
• Training & Quality Culture Development: Sustain and continue to develop QMS training programs to drive compliance, enhance quality awareness, and build a culture of accountability and continuous improvement.
• Process & Product Quality Improvement: Conduct process and product audits to identify gaps and drive continuous improvement initiatives using Lean and risk‑based methodologies.
• Customer Interface: Provide leadership as a key quality representative to customers, ensuring alignment with customer expectations. Complete all customer supplier audits, NAFTA, & Canadian export documentation.
• Supplier Quality Integration: Represent Quality on the Supplier Qualification Team & supplier performance reviews, ensure that Approved Supplier List (ASL), and supplier audits meet standards.
• Cross‑Functional Collaboration: Partner with Quality, Operations, Engineering, and other functions to implement QMS improvements that enhance efficiency, compliance, and product quality.
• Digital QMS Systems Management: Implement, maintain, and optimize QMS records, ensuring system effectiveness, data integrity, and user adoption.
• Management Review & Metrics: Support preparation and presentation of Management Review inputs, ensuring clear visibility to QMS performance, risks, and improvement opportunities.

Qualifications

• Bachelor’s degree or 4 years of equivalent work experience
• 2 years of experience managing Quality Management Systems
• Experience or understanding of ISO 13485
• Ability to prioritize work and manage multiple tasks when needed
• Consistently produce work that meets the customer’s requirements
• Project management skills
• Past quality assurance experience in a manufacturing environment strongly preferred
• Microsoft Office proficiency (Outlook, Word, Excel, PowerPoint)
• Clear and effective verbal and written communication skills

Benefits

• Medical, Dental, Vision, 401(k) with company match, Health Savings Account, Flexible Spending Account, Basic Life & Supplemental Life and AD&D Insurance, Disability Insurance, and on-site Fitness Center
• Prior to employment, all applicants are subject to a background check, physical, and drug screen.