Quality Engineering Lead, Medical Devices

Encore Medical LP; Austin (TX); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

401(k) Plan

Vacation, Sick Leave, and Holidays

Income Protection Plans

Discounted Insurance Rates

Legal Services

Job summary

Enovis seeks an Associate Manager, Quality Engineering to join the Quality Assurance team in Austin, TX. You will lead Quality Engineers, guide risk-based decisions on deviations, and support MRB activities, CAPA investigations, and supplier quality management.

You will oversee validations (IQ/OQ/PQ), monitor quality metrics, and collaborate with Manufacturing and Operations to drive continuous improvement while ensuring GMP, FDA, and ISO 13485 compliance.

Qualifications

• Bachelor's degree in Engineering, Science, or a related technical discipline.
• 5+ years of Quality Engineering, Manufacturing Engineering, or related experience within a regulated manufacturing environment.
• Experience within Medical Device, Aerospace, Automotive, or another highly regulated manufacturing industry required; medical device manufacturing experience strongly preferred.
• Previous experience leading projects, mentoring employees, serving as a technical lead, or providing day-to-day direction to a team.
• Experience with manufacturing transfers and process/equipment validation, including IQ/OQ/PQ, required.
• Demonstrated experience with root cause analysis, CAPA, nonconforming material, and structured problem-solving methodologies.
• Strong technical writing skills with demonstrated ability to develop, review, and approve quality documentation.
• Working knowledge of manufacturing processes with emphasis on metrology, precision machining, grinding, product cleaning, and sterilization.
• Proficiency with Microsoft Office applications, including Excel, Word, and PowerPoint.

Responsibilities

• Provide day-to-day guidance to Quality Engineers and other Quality team members.
• Assist in managing team priorities, resource allocation, and execution of departmental objectives.
• Coach and develop team members through regular feedback and training.
• Lead and support MRB activities, including evaluation and disposition of nonconforming material.
• Lead root cause and CAPA investigations and ensure corrective actions are verified.
• Lead or support process and equipment validations, including IQ/OQ/PQ/TMV.

Skills

Quality leadership

Root cause analysis

CAPA

Problem solving

Technical writing

Education

Bachelor's degree in Engineering, Science, or related field

Tools

IQ/OQ/PQ

Validation

Job description

Enovis seeks an Associate Manager, Quality Engineering to join the Quality Assurance team in Austin, TX. You will lead Quality Engineers, guide risk-based decisions on deviations, and support MRB activities, CAPA investigations, and supplier quality management.

You will oversee validations (IQ/OQ/PQ), monitor quality metrics, and collaborate with Manufacturing and Operations to drive continuous improvement while ensuring GMP, FDA, and ISO 13485 compliance.