Sr. Manager, Quality Systems (Medtech)

TL;DR

Sr. Manager, Quality Systems (Medtech): Designing, establishing, and improving the site Quality Management System (QMS) within a sterile cGMP manufacturing environment with an accent on regulatory compliance, document control, and data integrity. Focus on ensuring inspection readiness, managing CAPA and change control programs, and implementing electronic QMS solutions like TrackWise.

Location: On-site in Los Alamitos, California

Salary: $150,000 – $180,000

Company

hirify.global is a leading health and wellness platform redefining healthcare through personalized and accessible care.

What you will do

• Lead the design and continuous improvement of the site QMS in compliance with cGMP, 503B, and global standards.
• Implement and administer the site electronic QMS (TrackWise), managing data migration and process development.
• Own the document control system, ensuring data integrity (ALCOA+) and compliance with 21 CFR Part 11.
• Manage the Deviation and CAPA programs, conducting root cause analysis and ensuring timely closure.
• Drive the Change Control program and establish governance processes to enhance oversight and accountability.
• Develop the site training/competency program and manage the Learning Management System (LMS).
• Establish the internal audit program and support FDA and state board inspections, authoring responses to observations.

Requirements

• Bachelor’s degree in Life Sciences, Engineering, Quality, or a related field.
• 7+ years of progressive experience in Quality Assurance/Systems within an FDA-regulated environment.
• Must be based in or able to work on-site in Los Alamitos, California.
• Experience with sterile injectable cGMP or 503B is strongly preferred.
• Hands-on experience with eQMS (e.g., TrackWise) and deep knowledge of FDA, ISO, ICH, and EMA regulations.
• Proven experience supporting regulatory inspections and managing FDA Form 483 responses.

Culture & Benefits

• Competitive salary and equity compensation.
• Unlimited PTO, company holidays, and quarterly mental health days.
• Comprehensive medical, dental, and vision insurance, plus parental leave.
• 401k with employer matching and Employee Stock Purchase Program (ESPP).
• Offsite team retreats.