Quality Engineer - Medical Device | Process & CAPA Lead

Akkodis; San Diego (CA); On-site; USD 59,000 - 62,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Short-term disability

401K plan

Paid leave

Job summary

Akkodis is seeking a Quality Engineer in San Diego, CA 92121 (Onsite). The ideal candidate has 2+ years of engineering experience with quality tools and methodologies, and knowledge of FDA, GMP, ISO 13485, ISO 14971.

Strong communication and leadership skills are required, with experience in Six Sigma and Lean Manufacturing. Responsibilities include implementing process controls, CAPA systems, and leading cross‑functional teams to meet internal and external requirements.

Qualifications

• Minimum 2 years (2–5 years) engineering experience with quality tools/methodologies.
• Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971.
• Strong communication and interpersonal skills.
• Project management and leadership skills, including the ability to lead cross‑functional project teams and resolve quality issues in a timely and effective manner.
• Advanced computer skills, including statistical/data analysis and report writing; prior medical device experience preferred.
• Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing).

Responsibilities

• Identify and implement effective process control systems to support development, qualification, and ongoing manufacturing of products.
• Lead in the implementation of assurances, process controls, and CAPA systems.
• Assist in developing and executing streamlined business systems to identify and resolve quality issues.
• Apply sound, systematic problem‑solving methodologies to identify, prioritize, communicate, and resolve quality issues.
• Design and conduct experiments for process optimization and/or improvement.
• Document experiment plans and results, including protocol writing and reports.
• Lead process control and monitoring of CTQ parameters and specifications.

Skills

Problem solving

Statistical analysis

Data analysis

Communication

Leadership

Job description

Akkodis is seeking a Quality Engineer in San Diego, CA 92121 (Onsite). The ideal candidate has 2+ years of engineering experience with quality tools and methodologies, and knowledge of FDA, GMP, ISO 13485, ISO 14971.

Strong communication and leadership skills are required, with experience in Six Sigma and Lean Manufacturing. Responsibilities include implementing process controls, CAPA systems, and leading cross‑functional teams to meet internal and external requirements.