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