Quality Engineer | ISO Compliance & Process Improvement

Katalyst Surgical, LLC; Chesterfield (MO); On-site; USD 70,000 - 105,000; Full time

Benefits offered by this job

Medical

Vision

Dental

401k Matching

Employee Assistance Programs

Vacation and sick pay

Job summary

ZEISS in Chesterfield, MO is seeking a Quality Engineer to oversee QA processes, validations, and documentation to ensure regulatory compliance. The role focuses on maintaining high-quality standards across manufacturing operations and preparing for external audits.

The ideal candidate will lead continuous improvement initiatives, conduct internal audits, and collaborate with design and production teams to embed quality into every stage of manufacturing.

Qualifications

• Bachelor's degree in engineering, quality management or related field.
• 2–5 years of experience in quality assurance and validation in a manufacturing environment.
• ASQ Certified Quality Engineer or similar certification preferred.
• Strong knowledge of ISO 9001, ISO 13485, and ISO 14001 compliance.

Responsibilities

• Develop, implement, and maintain QA protocols aligned with regulatory requirements.
• Review quality metrics and performance indicators.
• Collaborate with cross-functional teams to integrate quality into production.
• Conduct internal audits and support external regulatory inspections.
• Maintain QA documentation and SOPs with proper archiving.
• Lead root-cause investigations and implement CAPA actions.
• Perform other duties as assigned by management.

Skills

Quality assurance

Root cause analysis

Validation

Regulatory compliance

Education

Bachelor's degree in engineering or quality management

Job description

ZEISS in Chesterfield, MO is seeking a Quality Engineer to oversee QA processes, validations, and documentation to ensure regulatory compliance. The role focuses on maintaining high-quality standards across manufacturing operations and preparing for external audits.

The ideal candidate will lead continuous improvement initiatives, conduct internal audits, and collaborate with design and production teams to embed quality into every stage of manufacturing.