Introduction

We are working with an innovative medical device company going through tremendous growth. They are seeking a Quality Assurance Specialist with a focus on CAPA and Root Cause Analysis.

This role will offer you

· Accelerated career growth on a team with a proven track record for internal growth.

· Work on state-of-the-art medical devices on the forefront of healing platforms.

You will be responsible for

· Oversee CAPA database and assure prompt completion of activities.

· Assist in investigations related to complaints, process, or material investigations.

· Assist with, and lead Root Cause Analysis (RCA).

· Perform standard quality assurance practices as needed.

· Become the subject-matter-expert.

You will bring the following

· BS in engineering or scientific background.

· Proven track record managing CAPA processes and facilitating change through process improvements.

· Strong knowledge of quality management systems, regulatory requirements, and industry standards.

· Proficient in the use of quality tools and methodologies (e.g., statistical analysis, Six Sigma, FMEA).

· Experience working with Contract Manufacturing Organizations (CMOs) is a plus.