Medical Device Quality Engineer – Onsite Austin

Enovis; Austin (TX); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

401(k) Plan

Vacation, Sick Leave, and Holidays

Job summary

Enovis Austin, TX is seeking a Medical Device Quality Engineer to support quality assurance activities, maintain procedures, and improve processes. The role ensures safety, quality, and regulatory compliance across the manufacturing environment.

As part of the Quality Team, you will participate in audits, root cause analyses, and CAPA, driving continuous improvement and patient outcomes in a regulated medical device setting.

Qualifications

• Basic understanding of good documentation practices and quality best practices.
• Ability to write clear, concise technical documentation.
• Proficiency in MS Office Suite (Excel, Word, PowerPoint).
• Must be able to lift 50 lbs and perform bending/twisting overhead movements.
• Experience in a regulated medical device environment is preferred.

Responsibilities

• Ensure compliance with GMP, ISO, FDA, and CMDR requirements.
• Support evaluation of product quality issues impacting safety or compliance.
• Assist with dispositions of nonconforming material through MRB reviews.
• Update or change quality standards, procedures, and work instructions.
• Assist with IQ/OQ/PQ equipment and process validations.
• Support supplier quality activities, including SCARs and audits.
• Perform trend analysis on production and quality data to identify improvements.
• Contribute to root cause investigations and CAPA activities.
• Partner with Manufacturing to address quality or compliance concerns.
• Participate in internal and external audits and assist with closure of findings.
• Support special projects as assigned.

Skills

Documentation practices

Technical writing

MS Office

Lifting 50 lbs

Education

Bachelors in Engineering/Science

Tools

SolidWorks

SolidWorks ePDM

Oracle R12

Agile PLM

Job description

Enovis Austin, TX is seeking a Medical Device Quality Engineer to support quality assurance activities, maintain procedures, and improve processes. The role ensures safety, quality, and regulatory compliance across the manufacturing environment.

As part of the Quality Team, you will participate in audits, root cause analyses, and CAPA, driving continuous improvement and patient outcomes in a regulated medical device setting.