Quality Engineer II - Quality Engineer III (San Diego - MedTech)

Job Description

Quality Engineer II - Quality Engineer III

\n

MedTech | San Diego, CA

\n

\n

The Opportunity

\n

Rincon Search Group is recruiting an experienced Quality Engineer on behalf of a rapidly growing client focused on the development and manufacture of cutting-edge interventional MedTech. The team is seeking a hands-on Quality Engineer who combines strong technical expertise with a proactive, manufacturing-focused approach.

\n

\n

This is an opportunity to join a growing team with significant potential for rapid career progression, increased responsibility, and professional development. The ideal candidate enjoys solving problems on the manufacturing floor, applying statistical methods to improve processes, and driving measurable quality improvements.

\n

\n

Key Responsibilities

\n

• Provide hands-on quality support to manufacturing, troubleshooting production issues and partnering with operators and engineers.

\n

• Develop and execute process validations, including IQ/OQ/PQ protocols, acceptance criteria, and validation reports.

\n

• Apply statistical tools, including process capability analysis (Cp/Cpk, Pp/Ppk), SPC, control charts, Gage R&R, and Design of Experiments.

\n

• Lead root cause investigations, CAPA, nonconformance resolution, and continuous improvement initiatives.

\n

• Develop and maintain PFMEAs, risk assessments, quality plans, and process documentation.

\n

• Support product launches, process development, metrology, and manufacturing process optimization.

\n

• Collaborate with Manufacturing, Engineering, customers, and suppliers to resolve quality issues and improve performance.

\n

\n

Qualifications

\n

• Five or more years of Quality Engineering or equivalent engineering experience, preferably in medical device manufacturing or other regulated environment.

\n

• Practical experience with process validation, statistical analysis, and manufacturing quality support.

\n

• Working knowledge of Lean, Six Sigma, root cause analysis, and continuous improvement methodologies.

\n

• Experience with SPC, Gage R&R, process capability, and preferably DOE, ANOVA, and regression.

\n

• Familiarity with ISO 13485, FDA quality requirements, CAPA, and risk management.

\n

• Strong technical writing, communication, and problem-solving skills.

\n

• Experience with Minitab or similar statistical software preferred. Power BI, Tableau, CQE, and Lean Six Sigma certifications are advantageous.

\n

• Bachelor’s degree in engineering or a related technical discipline, or equivalent experience.

\n

\n

Why Consider This Opportunity?

\n

Join a growing team where you can make a direct impact on manufacturing performance, product quality, and process development. With continued team expansion, there is substantial opportunity to take ownership of projects, broaden your technical expertise, and advance your career.

\n

\n

Work Authorization:

\n

Candidates must be authorized to work in the United States. Visa sponsorship is not available.