Senior Quality Engineer, NPI - Medical Devices

Stryker Group; Arroyo (PR); On-site; USD 70,000 - 111,000; Full time

Job summary

Stryker Group in Puerto Rico is seeking a Senior Quality Engineer for New Product Introduction to drive quality, compliance, and reliable transfers from development to production.

You will lead risk assessments, develop inspection methods (Gage R&R), manage PPAP with suppliers, and design validation plans with DOE while supporting design and manufacturing transfers and post‑launch quality monitoring.

Qualifications

• Bachelor’s degree in Engineering or related field.
• 4+ years in Quality/Manufacturing/New Product Introduction in a regulated industry.
• Experience with FDA QSR ISO standards and PPAP.
• Fluent in English and Spanish.
• Proficient in statistics, DOE, and process capability analysis.

Responsibilities

• Lead risk assessments and define preventive and detective quality controls across incoming materials, manufacturing processes, and product release activities.
• Develop, validate, and maintain inspection methods, including measurement system analysis (Gage R&R) and supplier correlation studies.
• Lead supplier component qualification activities through PPAP and verify implementation of quality controls at supplier sites.
• Develop and execute process validation strategies, including statistical rationale, sample size justification, and worst‑case testing.
• Partner with engineering teams to support product design transfers and manufacturing transfers with design control compliance.
• Develop and execute sterilization validation activities in collaboration with SMEs and document results.
• Monitor post-launch product performance by analyzing quality metrics and leading investigations and CAPA.
• Train quality personnel and support audits to ensure regulatory compliance.

Skills

English

Spanish

Risk assessment

Statistical analysis

Process validation

Supplier quality

Quality leadership

Education

Bachelor’s degree in Engineering or related field

Tools

Gage R&R

PPAP

DOE

Job description

Stryker Group in Puerto Rico is seeking a Senior Quality Engineer for New Product Introduction to drive quality, compliance, and reliable transfers from development to production.

You will lead risk assessments, develop inspection methods (Gage R&R), manage PPAP with suppliers, and design validation plans with DOE while supporting design and manufacturing transfers and post‑launch quality monitoring.