Quality Engineer I / II / Quality Assurance Engineer

My client is a contract development and manufacturing organization in regenerative medicine, producing allograft and xenograft biomaterials used in surgical procedures. This Quality Engineer role investigates and resolves product nonconformities, hands-on work in a facility that handles human donor tissue.

Why you should apply

• Direct, visible impact: your calls decide whether product ships, in a facility working with human donor tissue.
• A growth-focused team, where curiosity counts as much as tenure.
• Practical depth in ISO 13485:2016 and ISO 14971:2019, plus complaint handling and manufacturing support.
• Base salary of $65,000 to $90,000 by level, plus a $5,000 to $8,000 bonus target.
• Onsite in Alachua, FL.

What you'll be doing

• Investigate and disposition product nonconformities and complaints
• Support manufacturing and process quality on the floor
• Maintain documentation to FDA and ISO standards
• Apply ISO 13485:2016 and ISO 14971:2019 day to day
• Support new product development activities as needed
• Work directly with human tissue as part of the donor process

About you

• Be able to do the job as described.
• Comfortable working hands-on with human tissue and donor materials
• A documentation-first mindset
• Curious and eager to learn, not arriving having already seen it all
• Bachelor's degree in a relevant technical discipline