Medical Device Quality Engineer

Enovis•Austin, TX

5d•Onsite

About The Position

As a key member of the Quality Team, you will support Enovis in helping drive the medical technology industry forward by supporting quality processes, patient safety, and compliance. Utilizing foundational knowledge of engineering and problem-solving principles, this position is responsible for supporting quality assurance activities related to the implementation, maintenance, and improvement of procedures and work instructions to help ensure safety, quality, and compliance with Company standards and government regulations.

Requirements

Bachelor’s degree in Engineering, Science, or related technical field and 0–2 years of experience, preferably in medical device manufacturing
Required knowledge of FDA/GMP, CMDR, MDD and ISO 13485 quality standards.
Basic understanding of good documentation practices, and quality best practices.
Demonstrated ability to write clear, concise technical documentation.
Must be able to work 100% onsite at Austin manufacturing facility
Proficiency in MS Office Suite, including Excel, Word and PowerPoint
Must be able to lift 50 lbs.
Must be able to bend, twist, and lift overhead.

Nice To Haves

Internship, co-op, or prior experience in manufacturing, quality, engineering, in a regulated industry preferred.
Exposure to manufacturing equipment transfers and validation activities, including IQ/OQ/PQ, preferred.
Background or coursework related to Medical Device, Pharmaceuticals, or another regulated industry preferred.
Basic knowledge of ISO 13485 quality standards preferred.
Basic familiarity with quality and problem-solving tools (e.g., DMAIC, FMEA, statistical analysis) preferred.
Basic knowledge of manufacturing processes preferred, including precision machining, finishing, inspection, product cleaning, and sterilization.
Basic knowledge of Geometric Dimensioning & Tolerancing (GD&T) preferred.
Preferred exposure to the following software packages: SolidWorks, SolidWorks ePDM, Oracle R12, and Agile PLM.
CQE, Lean, or Six Sigma exposure or certification preferred, but not required.

Responsibilities

Ensuring compliance with internal and external specifications and standards, including GMP, ISO, FDA, and C MDR requirements.
Supporting evaluation of product quality issues that may impact device performance, patient safety, or regulatory compliance.
Supporting the evaluation of nonconforming material and assisting with dispositions through cross-functional engineering review as part of the MRB.
Supporting updates or changes to quality standards, procedures, and work instructions.
Assisting with process and equipment validations, including IQ/OQ/PQ documentation.
Supporting supplier quality activities, including review of incoming nonconformances, supplier corrective actions (SCARs), audits, and supplier performance monitoring.
Performing trend analysis on production and quality data to identify improvement opportunities.
Contributing to root cause investigations using structured problem-solving methods.
Contributing to CAPA activities, including investigation, documentation, and effectiveness verification.
Partnering with Manufacturing and Operations to help address quality or compliance concerns.
Participating in internal and external audits, including audit preparation, providing support during audits, and assisting with closure of findings.
Supporting special projects as assigned.