Senior NPI Quality Engineer - Medical Devices & Validation

Regulatory Jobs

Arroyo (PR)

On-site

USD 70,000 - 111,000

Full time

14 days+

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Job summary

Stryker Corporation in Puerto Rico is seeking a Senior Quality Engineer, New Product Introduction, to help bring new medical technologies into production while ensuring quality, compliance, and process reliability. You will partner with cross-functional teams and suppliers to support product development, transfers, validation, and post-launch monitoring across the lifecycle.

The role requires a Bachelor’s degree in engineering and 4+ years in quality or manufacturing engineering within regulated

Qualifications

Bachelor’s degree in Engineering or related field.
4+ years of experience in Quality/Manufacturing Engineering in a regulated industry.
Experience with FDA QSR/ISO standards.
Fluent in English and Spanish (written and spoken).
Experience with PPAP and supplier quality activities.
Knowledge of statistical methods and DOE.

Responsibilities

Lead risk assessments and implement quality controls across materials, processes, and release activities.
Develop, validate, and maintain inspection methods, including Gage R&R and accuracy verification.
Lead supplier qualification through PPAP and verify supplier quality controls.
Develop process validation strategies with statistical justification and worst-case testing.
Support design and manufacturing transfers, ensuring design control compliance.
Monitor post-launch quality, analyze metrics, lead CAPA, and support audits.