Quality Manager | ISO 9001 Quality Systems Leadership

Strategic Employment Partners (SEP); Monroe (OH); Hybrid; USD 90,000 - 130,000; Full time

Benefits offered by this job

Hybrid work model

401(k) match

Comprehensive benefits

Job summary

Strategic Employment Partners (SEP) is seeking a Quality Manager to own the QMS for a core product line at a global manufacturer of temperature-controlled packaging solutions. This leadership role drives ISO 9001 compliance, CAPA, supplier and customer quality, and cross-functional quality initiatives.

The successful candidate will lead a small quality team, influence manufacturing, engineering, and operations, and contribute to new product initiatives with a path toward Director-level

Qualifications

• Own and maintain enterprise ISO 9001 Quality Management System (QMS).
• Lead and improve CAPA, audits, and documentation control.
• Manage supplier quality programs and performance.
• Direct customer-facing quality activities including complaint investigation and corrective actions.
• Influence cross-functional teams across manufacturing, engineering, operations, and leadership.
• Regulated manufacturing environment experience preferred (packaging/life sciences/pharma).
• ISO 9001 experience required; ISO 13485/14001 preferred.

Responsibilities

• Own the QMS and ensure ISO compliance across operations.
• Lead internal and external audits and supplier qualifications.
• Drive corrective and preventive actions and root-cause analysis.
• Manage customer quality concerns through resolution and continuous improvement.
• Guide a small quality team and collaborate with leadership for strategic initiatives.
• Support new product initiatives with quality leadership.

Skills

QMS ownership

Quality leadership

Audits

CAPA

Cross-functional leadership

Supplier quality management

Education

Bachelor's degree

Tools

Quality management software

Job description

Quality Manager | Quality Management System Owner | ISO 9001 | Director Track

A global manufacturer of temperature-controlled packaging solutions serving the pharmaceutical and life sciences markets is seeking a Quality Manager to lead and own quality for one of its core product lines.

This is a highly visible quality leadership position responsible for the overall effectiveness, execution, and continuous improvement of the Quality Management System (QMS). The Quality Manager will serve as the primary owner of the QMS, with full responsibility for maintaining ISO 9001 compliance and driving quality performance across manufacturing operations, supplier quality, customer quality, and quality systems.

Managing a small quality team, this individual will lead internal and external audits, oversee supplier qualification and performance, drive corrective and preventive actions, manage customer quality concerns through resolution, and partner closely with manufacturing, engineering, operations, and leadership teams.

This is a true manufacturing quality leadership opportunity, not a support, coordinator, or compliance-focused role. The successful candidate will have demonstrated experience owning and leading a quality management system, influencing cross-functional stakeholders, and building a culture of quality across the organization. The Quality Manager will also play a key role in several new product initiatives and strategic business projects.

Key Requirements

• Demonstrated ownership of an enterprise-wide ISO 9001 Quality Management System
• Experience leading, maintaining, and continuously improving all aspects of the QMS, including documentation control, CAPA, audits, supplier quality, and management review processes
• Strong leadership experience with 5-7+ years of people management and responsibility for both strategic and day-to-day quality operations
• Proven experience managing supplier quality and supplier performance programs
• Experience leading internal, external, and certification audits
• Direct customer-facing quality experience, including complaint investigation, root cause analysis, and corrective actions
• Background within packaging, manufacturing, life sciences, medical device, pharmaceutical, consumer products, or other regulated manufacturing environments
• ISO 9001 experience required
• ISO 13485 and/or ISO 14001 experience strongly preferred
• Demonstrated ability to influence cross-functional teams and drive quality initiatives across manufacturing operations

Why This Opportunity

• Own and lead the Quality Management System for a critical product line within a growing global organization
• High-impact leadership role with responsibility for quality systems, supplier quality, manufacturing quality, and customer quality
• Excellent visibility with executive leadership and a clearly defined path toward Director-level responsibility
• Opportunity to influence new product development and strategic quality initiatives across the business
• Competitive compensation package, comprehensive benefits, 401(k) match, and hybrid work flexibility (4 days onsite, 1 day remote)