DeRoyal is an Equal Opportunity/Affirmative Action employer. Interviewing and hiring practices at DeRoyal do not discriminate on the basis of race, color, sex, sexual orientation, gender identity, age, national origin, physical or mental disability, genetic information, veteran status or any other category protected by law.

2150 - 1579 Quality Operations Manager

Come join our team!

Global medical device manufacturer, DeRoyal, is seeking a Quality Operations Manager to lead and enhance quality processes within our manufacturing operations. This role is responsible for ensuring product quality, regulatory compliance, and operational excellence while driving continuous improvement initiatives. The ideal candidate will bring strong leadership, analytical skills, and experience in quality systems within a regulated environment.

Key Responsibilities

• Lead and implement quality control processes across the production lifecycle
• Partner with manufacturing teams to resolve quality issues
• Maintain and improve quality management systems
• Oversee customer complaint investigations and CAPA processes
• Ensure compliance with FDA QSR and ISO 13485 standards
• Lead audit preparation and execution
• Analyze data and present findings to leadership
• Drive continuous improvement initiatives
• Manage customer and vendor quality relationships

Qualifications

• Bachelor’s degree or minimum of 8+ years of relevant experience required; or a combination of education and relevant work experience
• Knowledge of FDA regulations and ISO standards
• Strong analytical and communication skills
• Proficiency in Microsoft Office

Why Join DeRoyal

• Collaborative, quality-driven culture
• Opportunities for process improvement leadership
• Commitment to innovation and patient-focused products

Learn more about this Employer on their Career Site