Senior Quality Engineer, New Product Introduction (24 Months fixed term)

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

As a Senior Quality Engineer, New Product Introduction, you will play a key role in bringing 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, manufacturing transfers, process validation, and post‑launch monitoring across the product lifecycle.

What You Will Do

• 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 Production Part Approval Process (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.

What You Will Need

Required

• Bachelor's degree in Engineering, Quality, Manufacturing, Industrial Engineering, or a related technical field.
• Minimum 4 years of experience in Quality Engineering, Manufacturing Engineering, New Product Introduction, or Process Validation within a regulated industry.
• Experience applying process validation principles in accordance with FDA Quality System Regulation and ISO standards.
• Fluent English and Spanish (written and spoken).
• Experience with Production Part Approval Process (PPAP), risk management methodologies, and supplier quality activities.
• Experience using statistical tools and methods, including hypothesis testing, process capability analysis, design of experiments (DOE), and data interpretation.

Preferred

• Experience supporting sterilization validation and sterile packaging processes.
• Experience working with manufacturing transfers, design transfer activities, and medical device quality systems.
• Puerto Rico: $69,500 - $110,900 USD Annual

Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short‑term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.