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

Stryker Corporation; Arroyo (PR); On-site; Confidential; Full time

Job summary

Stryker Corporation in Puerto Rico is seeking a Senior Quality Engineer for New Product Introduction to drive quality, compliance, and process reliability from development to production. You will partner with engineering, manufacturing, and suppliers to support product transfers and validation across the lifecycle.

The role requires a Bachelor's in engineering, at least 4 years in quality or process validation in regulated environments, fluency in English and Spanish, experience with PPAP, risk

Qualifications

• Bachelor’s degree in Engineering, Quality, Manufacturing, Industrial Engineering, or related field.
• Minimum 4 years of experience in Quality or Manufacturing Engineering, NPI, or Process Validation in a regulated setting.
• Experience applying process validation per FDA QSR and ISO standards.
• Fluent in English and Spanish (written and spoken).
• Experience with PPAP, risk management, and supplier quality activities.
• Experience using statistical tools and methods (DOE, hypothesis testing, capability studies).

Responsibilities

• Lead risk assessments and define preventive and detective quality controls across materials, processes, and product release.
• Develop, validate, and maintain inspection methods, including Gage R&R and supplier correlation studies.
• Lead PPAP activities and verify supplier quality controls at supplier sites.
• Develop and execute process validation strategies with statistical rationale and DOE.
• Collaborate with engineering on design and manufacturing transfers ensuring regulatory compliance.
• Coordinate sterilization validation activities and document outcomes.
• Monitor post-launch performance, analyze quality metrics, and drive corrective actions.
• Train quality personnel and support audits to maintain compliance.

Skills

Quality Engineering

New Product Introduction

Process Validation

PPAP

Risk Management

Statistical Tools

Supplier Quality

English proficiency

Spanish proficiency

Education

Bachelor’s degree in Engineering or related technical field

Tools

Gage R&R

Job description

Work Flexibility

Onsite 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.

Location and Compensation

Puerto Rico: $69,500 - $110,900 USD Annual Travel Percentage: None

Equal Opportunity

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability. Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.

About Stryker

Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. We are proud to be named one of the World’s Best Workplaces! For more information, visit: www.stryker.com

Work Flexibility

Remote – Role allows you to work the majority to 100% of time from an alternate workplace. These roles could have travel expectations, and you must work within the country of the job requisition location. Field‑based – You can expect to regularly work a majority to 100% of time at customer facilities and has a set territory or expectation to travel within a set boundary. Almost all sales roles would likely be qualified as field‑based. Onsite – Role is 100% located at a Stryker facility. Some ad hoc flexibility may be available depending on role, level, and job requirements. Manufacturing roles and any role that requires physical presence at the office would qualify under this category. Hybrid – You can expect to regularly work in both an alternate workplace and a Stryker facility. Roles that are partially remote or co‑located would qualify as hybrid, and the expectation to be onsite would be defined and agreed upon by your manager/supervisor.