Senior Quality Engineer, NPI — Medical Devices

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

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

HSA

FSAs

401(k) plan

ESPP

Life insurance

AD&D insurance

Short-term disability

Wellbeing program

Tobacco cessation

Job summary

Stryker is seeking a Senior Quality Engineer for New Product Introduction to bring advanced medical technologies from development into production while ensuring quality and compliance. You will lead risk assessments, establish quality controls, guide design and manufacturing transfers, and drive validation and post-launch monitoring across the product lifecycle.

The role requires a strong background in FDA QSR/ISO standards, PPAP, and statistical methods, with fluency in English and Spanish.

Qualifications

• Bachelor's degree in Engineering, Quality, Manufacturing, Industrial Engineering, or related field.
• 4+ years in Quality/Manufacturing/New Product Introduction in a regulated industry.
• Experience with FDA QSR and ISO standards.
• Fluent English and Spanish.
• Experience with PPAP, risk management, supplier quality.
• Experience using statistical methods: hypothesis testing, capability analysis, DOE, data interpretation.

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), accuracy verification, 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, performance qualification activities, and worst‑case condition testing.
• Partner with engineering teams to support product design transfers and manufacturing transfers, ensuring compliance with design control and regulatory requirements.
• Develop and execute sterilization validation activities in collaboration with subject matter experts, including documentation of validation outcomes.
• Monitor post‑launch product performance by analyzing quality metrics, reporting process indicators, and leading investigations, corrective actions, and preventive actions for nonconformances.
• Train quality personnel and support internal and external audits while maintaining compliance with applicable quality and regulatory requirements.

Skills

Quality engineering

Risk management

Statistical analysis

Process validation

PPAP

DOE

Gage R&R

Supplier quality

Education

Bachelor's degree in Engineering or related

Job description

Stryker is seeking a Senior Quality Engineer for New Product Introduction to bring advanced medical technologies from development into production while ensuring quality and compliance. You will lead risk assessments, establish quality controls, guide design and manufacturing transfers, and drive validation and post-launch monitoring across the product lifecycle.

The role requires a strong background in FDA QSR/ISO standards, PPAP, and statistical methods, with fluency in English and Spanish.