Senior Quality Engineer, New Product Introduction

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

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.

Skills

Risk assessment

PPAP

Gage R&R

DOE

Statistical analysis

Process validation

Regulatory compliance

Cross-functional teamwork

Bilingual EN/ES

Education

Bachelor's degree in Engineering

Tools

Statistical software

DOE tools

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.

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

Travel Percentage: None

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.