Quality Control Manager (Medtech)

TL;DR

Quality Control Manager (Medtech): Leading quality control execution across manufacturing and receiving operations with an accent on regulatory compliance, inspection strategy, and team leadership. Focus on maintaining high standards for medical device production, managing nonconformances, and driving continuous improvement initiatives in a fast-paced environment.

Location: Must be based in Orange County, CA

Salary: $112,000 - $145,000

Company

hirify.global is a leading digital healthcare company that combines wearable biosensors and cloud-based data analytics to provide actionable cardiac health information.

What you will do

• Lead, coach, and develop Manufacturing Quality Inspectors and Receiving Inspection personnel.
• Support the development and implementation of inspection plans, sampling strategies, and control plans.
• Ensure timely identification, documentation, and containment of nonconforming material.
• Own the review, verification, and acceptance of manufacturing batch records and travelers.
• Oversee calibration and preventive maintenance programs for inspection equipment.
• Monitor QC-related metrics to proactively identify compliance risks and drive continuous improvement.

Requirements

• Bachelor’s Degree in Life Sciences, Engineering, or related technical discipline required.
• Minimum of 8 years of progressive experience in a medical device manufacturing environment.
• Strong working knowledge of ISO 13485 and FDA 21 CFR Part 820.
• Demonstrated ability to resolve complex quality issues, including nonconformances and MRB activities.
• Working knowledge of statistical tools, process capability, and risk management (ISO 14971).
• Excellent communication skills with the ability to lead and mentor teams.

Culture & Benefits

• Opportunity to work on life-changing cardiac health solutions.
• Collaborative and fast-paced environment focused on patient care.
• Commitment to an inclusive workforce and equal opportunity employment.
• Focus on professional growth and career development.