Quality Assurance Engineering Supervisor (Medical Devices)

TL;DR

Quality Assurance Engineering Supervisor (Medical Devices): Supervising the Quality System and QA Engineering Specialists to ensure regulatory compliance with an accent on team leadership, workload prioritization, and process optimization. Focus on defending Quality System processes during FDA and State Agency audits and implementing lean system improvements.

Location: On-site in Roseville, CA

Salary: $80,000 – $110,000

Company

hirify.global is a global healthcare company focused on innovative therapies and the design, manufacture, and marketing of novel medical products.

What you will do

• Supervise and mentor QA Engineering Specialists, including conducting annual performance evaluations and creating professional growth plans.
• Coordinate scheduling, prioritization, and workload for the QA team to ensure adequate coverage.
• Evaluate and improve procedures and work instructions to make systems leaner and more intelligent.
• Support and defend Quality System processes during internal, notified body, FDA, and State Agencies audits.
• Communicate Quality System issues to upper management and present appropriate solutions.
• Ensure departmental adherence to the Quality Management System (QMS), global regulations, and standards.

Requirements

• Bachelor's degree with 2+ years of experience in Quality Assurance, Quality Control, biotechnology, or document control.
• Must be based in or able to work on-site in Roseville, CA.
• Thorough knowledge and understanding of FDA’s QSR, ISO standards, and MDD/MDR.
• Proficiency with MasterControl and Microsoft Professional Office Suite (Word, Excel, Access, PowerPoint).
• Solid problem-solving, decision-making, and leadership skills.
• Strong oral, written, and interpersonal communication skills.

Nice to have

• Prior supervisory experience.

Culture & Benefits

• Collaborative teamwork environment where learning is constant and performance is rewarded.
• Comprehensive benefits package including medical, dental, vision, life, AD&D, and short/long-term disability insurance.
• 401(k) with employer match.
• Paid parental leave, sick time, and a minimum of fifteen days of accrued vacation per year (increasing with tenure).
• Eleven paid company holidays per year.