Quality Supervisor (Medical Devices)

TL;DR

Quality Supervisor (Medical Devices): Leading all quality activities at a diagnostic kitting and distribution facility with an accent on building and running the day-to-day quality system. Focus on managing nonconformance and CAPA processes, ensuring regulatory compliance in an IVD environment, and establishing rigorous warehouse and storage controls.

Location: On-site in New Albany, Ohio

Company

A leading health and wellness platform redefining healthcare through affordable and personalized care from diagnosis to treatment.

What you will do

• Establish and maintain quality requirements for warehouse storage, including temperature, humidity, and environmental controls.
• Manage incoming receipt and component inspection procedures for diagnostic kitting materials.
• Oversee kitting operations quality by creating SOPs, batch records, and performing in-process inspections.
• Execute customer quality complaint evaluations and investigations, tracking trends for process improvement.
• Own the site's nonconformance (NC) and CAPA program, utilizing root cause analysis tools like 5-Why and fishbone.
• Manage document and change control processes, including the issuance and retirement of SOPs and work instructions.

Requirements

• Bachelor's degree in Life Sciences, Engineering, Quality Management, or a related field.
• 4–6 years of quality experience in a regulated medical device, IVD, or closely related healthcare environment.
• Demonstrated experience writing and implementing SOPs, work instructions, and batch records.
• Hands-on experience owning and running a nonconformance and CAPA system.
• Strong written communication skills for maintaining documentation in a regulated environment.
• Must be able to work on-site in a warehouse and kitting environment, including occasional lifting up to 30 lbs.

Culture & Benefits

• Competitive salary and equity compensation for full-time roles.
• Unlimited PTO, company holidays, and quarterly mental health days.
• Comprehensive health benefits including medical, dental, vision, and parental leave.
• 401k with employer matching contribution and Employee Stock Purchase Program (ESPP).
• Offsite team retreats.