Manager, Quality Engineering

Strivector Corp is a National Recruiting and Staffing agency established in 2012 and headquartered in Austin, Texas. We are a preferred partner for several Fortune 500 companies nationwide. Strivector has been consistently rated a rare 4.6/5 on Google, Indeed and Glassdoor by our candidates, customers, employees and contractors.

Elevate your professional journey with us. Strivector's premier client (a well-known market leader in their space) is hiring for the following full-time direct hire position.

POSITION OVERVIEW

As a Manager, Quality Engineering your roles and responsibilities will include:


The Manager, Quality Engineering is responsible for leading and coordinating all quality and regulatory compliance activities for a designated business unit within the Columbus manufacturing facility. This role provides leadership for Quality Systems, Quality Engineering, and Sterilization Control to ensure products meet quality, regulatory, and customer requirements throughout molding, assembly, packaging, sterilization, and product release operations.
The position reports to the Associate Director of Quality Management and works closely with business unit leadership to drive quality excellence, regulatory compliance, continuous improvement, and customer satisfaction in a high-volume manufacturing environment.
Key Responsibilities
Quality Leadership

• Lead Quality Systems and Quality Engineering activities for the assigned business unit.
• Provide strategic quality direction aligned with corporate and business objectives.
• Serve as the quality representative for business unit leadership teams.
• Build and develop high-performing Quality Engineering and Quality Representative teams.
• Mentor and coach quality professionals to strengthen organizational capability.

Regulatory & Compliance

• Ensure compliance with FDA, ISO, and other applicable global regulatory requirements.
• Act as the management representative for Quality System compliance matters.
• Interface with regulatory agencies and external auditors.
• Lead customer audits, regulatory inspections, and internal audits.
• Maintain strong compliance with quality management systems and procedures.

Quality Systems & Continuous Improvement

• Drive CAPA (Corrective and Preventive Action) programs to reduce complaints, non-conformances, waste, and rejections.
• Evaluate and improve quality systems, processes, and controls.
• Support and lead continuous improvement initiatives utilizing Lean and Six Sigma methodologies.
• Champion zero-customer-complaint initiatives and customer-focused quality improvements.
• Support 5S, waste reduction, operational excellence, and business performance objectives.

Validation & Manufacturing Support

• Lead and support validations involving products, materials, manufacturing processes, and projects.
• Support molding, assembly, packaging, sterilization, and product release activities.
• Partner with Manufacturing, Engineering, R&D, Regulatory Affairs, and Operations teams to achieve business goals.
• Ensure quality standards are maintained in a high-volume production environment.

QUALIFICATIONS

Most importantly, you need to be a passionate Manager, Quality Engineering who enjoys his work and is considered to be one of the best within your organization. The ideal Manager, Quality Engineering would be someone with deep experience in many (if not all) of the following:
Required Qualifications

• Bachelor's degree in Engineering, Science, or a related technical field.
• Minimum 5 years of quality experience.
• Minimum 3 years of medical device manufacturing experience.
• Experience with:
  • CAPA programs
  • Process/Product Validation (IQ/OQ/PQ)
  • Statistical Analysis and Quality Tools
  • High-volume manufacturing environments
  • Lean Manufacturing and/or Six Sigma methodologies
• Previous people management and leadership experience.
• Strong communication skills with the ability to influence all organizational levels.
• Ability to prioritize and perform effectively in a fast-paced manufacturing environment.
• Willingness to support a 24/7 manufacturing operation.

We understand that even if you are a seasoned Manager, Quality Engineering you may not have all the skills listed here.


ADDITIONAL INFORMATION
Compensation: Based on Experience. One of the best in the industry
Minimum Education: Bachelor's degree in Engineering, Science, or a related technical field.
Minimum Experience: Must have at least 5 years of quality experience, including a minimum of 3 years in FDA/ISO-regulated medical device manufacturing, with hands-on experience in CAPA, validation, and quality systems.

Type of position: Full-time Permanent position with benefits
Location: Columbus, Nebraska

Remote / Hybrid: No
Relocation accepted: Yes, Full relocation benefits are provided