Quality Manager ISO 9001 QMS Leadership

Strategic Employment; Monroe (OH); Híbrido; USD 95.000 - 125.000; Jornada completa

Descripción de la vacante

Strategic Employment in Monroe, Ohio is seeking a hands-on Quality Manager to own quality for a core parcel packaging product line within the temperature-controlled life sciences space.

The role leads a small quality team, drives ISO 9001 and ISO 14001 compliance, and manages customer quality concerns from inquiry through resolution. Hybrid work arrangement offered with four days onsite and one remote day.

Formación

• Ownership of ISO 9001 and ISO 14001 QMS.
• 5–7+ years of formal people leadership experience.
• Experience leading internal and external quality audits.
• Direct customer-facing quality issue resolution experience.
• Background in packaging, light manufacturing, life sciences, medical/pharma or consumer products.
• ISO 13485 and/or FDA regulated environment experience is a plus, but not required.

Responsabilidades

• Own quality for core parcel packaging product line.
• Lead internal and external quality audits.
• Oversee supplier and manufacturing quality performance.
• Manage customer quality concerns from inquiry to resolution.
• Support several new product initiatives across the business.

Conocimientos

ISO 9001/ISO 14001 QMS ownership

People leadership

Quality audits

Customer-facing quality

Packaging / life sciences background

Regulated environments awareness

Descripción del empleo

This is a hands-on leadership role with a direct track to responsible for managing a small quality team, leading internal and external quality audits, overseeing supplier and manufacturing quality performance, and managing customer quality concerns from initial inquiry through resolution. This position is centered around ownership of the ISO 9001 and ISO 14001 quality management systems and is a true manufacturing quality leadership role, not a purely regulatory or compliance-focused position. The Quality Manager will also play an active role in several new product initiatives being launched across the business.

Key Requirements:

• Demonstrated ownership of both ISO 9001 and ISO 14001 quality management systems
• 5-7+ years of formal people leadership experience with both strategic and tactical responsibilities
• Experience leading internal and/or external quality audits
• Direct customer-facing quality issue resolution experience
• Background within packaging, light manufacturing, life sciences manufacturing, medical products, pharmaceutical manufacturing, or consumer products manufacturing environments
  
• ISO 13485 and/or FDA regulated environment experience is a plus, but not required

This position offers a defined path toward a Director-level role for an individual interested in building a long-term career within the temperature-controlled packaging and life sciences industry.

Location:Monroe, Ohio area
Work Arrangement: Hybrid (4 days onsite, 1 day remote)

Global manufacturer of temperature-controlled packaging solutions for the pharmaceutical and life sciences industry is seeking a Quality Manager to own quality for one of its core parcel packaging product lines.