Medical Device Product Quality Engineer — CAPA & RCA Lead

Centese; Omaha (NE); On-site; USD 70,000 - 90,000; Full time

Job summary

A medical device startup is seeking a Product Quality Engineer to lead post-market investigations and risk-based improvements. The role involves collaborating with Quality, Manufacturing, and R&D teams to resolve product issues and requires strong mechanical engineering skills. Ideal candidates will hold a Bachelor's degree in Mechanical or Biomedical Engineering and have at least 3 years of relevant experience. The position is located in Omaha, NE, and relocation is not provided.

Qualifications

• 3+ years of experience in product quality engineering or manufacturing engineering.
• Strong knowledge of FDA and ISO regulations.
• Ability to manage multiple projects in a fast-paced environment.

Responsibilities

• Lead investigations into product non-conformance issues.
• Document findings from root-cause analysis.
• Collaborate with teams to resolve issues efficiently.

Skills

Non-conformance management

Root cause analysis

Corrective action techniques

Problem-solving

Communication skills

Education

Bachelor's degree in Mechanical or Biomedical Engineering

Tools

MathWorks MATLAB

Job description

A medical device startup is seeking a Product Quality Engineer to lead post-market investigations and risk-based improvements. The role involves collaborating with Quality, Manufacturing, and R&D teams to resolve product issues and requires strong mechanical engineering skills. Ideal candidates will hold a Bachelor's degree in Mechanical or Biomedical Engineering and have at least 3 years of relevant experience. The position is located in Omaha, NE, and relocation is not provided.