Quality Engineer - Medical Device

Quality Engineer - Medical Device at Kensington360 Quality Engineer - Medical Device at Kensington360 in San Antonio, Texas Posted in 11 days ago.

Type:

full-time

Job Description:

Quality Engineer - Medical Device | Additive Manufacturing Why this role stands out: Work at the cutting edge of additive manufacturing in medical devices High-impact role with real ownership of validation and process quality Opportunity to help build and shape quality systems from the ground up Close collaboration with senior leadership and external experts Clear progression as the site scales into full production The Role You'll take ownership of process validation and manufacturing quality , ensuring advanced manufacturing processes are robust, compliant, and scalable. This is a hands-on, technical role where you'll lead

IQ/OQ/PQ

activities , drive process improvements, and act as the go-to expert for manufacturing quality. What you'll be doing Leading validation activities across manufacturing processes Driving process control using SPC and data analysis Investigating nonconformances and implementing corrective actions Developing SOPs and supporting regulatory documentation Working closely with QA, suppliers, and leadership What we're looking for Quality Engineer with experience in regulated environments (medical device preferred) Strong background in process validation (IQ/OQ/PQ) Knowledge of

ISO 13485 / FDA

regulations Experience with SPC, MSA, and root cause analysis Ideally exposure to additive manufacturing or advanced manufacturing technologies Why apply? This is a rare opportunity to step into a high-visibility role in a growing, advanced manufacturing environment , where your work will directly shape processes, quality systems, and long-term success.