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Skills: Quality Management System, ISO 13485, CAPA Management, Internal Auditing, Root Cause Analysis
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$90k–$110k/yr
Full-time
bachelor degree
Medical Insurance, Dental Insurance, Vision Insurance, 401(k) With Company Match, Health Savings Account, Flexible Spending Account
Posted 15d ago
~40 hrs/week
Responsibilities
The Quality Process Manager is responsible for developing and maintaining a Quality Management System compliant with ISO 13485 and global regulatory standards. Key duties include leading audits, managing CAPA and complaint functions, and partnering cross-functionally to embed quality throughout the product lifecycle.
Requirements
Candidates need a bachelor's degree or equivalent experience, along with at least 2 years of experience managing Quality Management Systems. Proficiency in ISO 13485 and experience in a manufacturing environment are strongly preferred.
Full job description
Overview:
About Central Package:
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 customer requirements. 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 $110,000-130,000 based on a candidates 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 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 and customer regulations.
CAPA & Complaint Management Oversight
Lead CAPA functions 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 meets standards.
Cross-Functional Collaboration
Partner with Design, Operations, and other departments 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.
Bachelor’s degree or 4 years of equivalent work experience
2 years of experience managing Quality Management Systems
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
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.
Related keywords
ISO 13485QMSCAPARoot Cause AnalysisLeanMedical Device IndustryInternal AuditSupplier QualificationDocument ControlRegulatory ComplianceNAFTACanadian Export DocumentationManagement ReviewData Integrity
CENTRAL PACKAGE & DISPLAY
Delivering More Than Packaging
Central Package & Display is a leading manufacturer of Corrugated Protective packaging, POP displays, and POS packaging. CPD is unique in having Folding carton and Set Up box operations under the same roof as our corrugated products. As such, we offer fully integrated design and production capabilities.
If you're looking for a packaging supplier that's experienced, creative and dedicated to quality, you've come to the right place. With over 50 years of consumer and business packaging expertise, CPD Corporation has a broad array of packaging capabilities and the facilities to be your central resource for all your packaging needs.
Central Package & Display collaborates with you on your entire project. From innovative custom concepts to structural prototypes, production through distribution; when you work with Central Package & Display, you're working with a team of experienced packaging specialists who know how to design, develop, produce and fulfill your packaging needs.
Offices: 3901 85th Avenue North, Minneapolis, MN 55443-1907, US
How much do Management & Leadership jobs in Minnesota pay?
Based on 5370 listings with disclosed salaries, most management & leadership jobs in Minnesota pay between $68k–$170k per year. Individual offers vary with seniority, company size, and specialization.
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