Senior Quality Engineer, New Product Introduction (24 Months Fixed-Term) (On-site)

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 lead quality controls, validation, and regulatory compliance across product launches.

You will partner with engineering and supplier teams to ensure design and manufacturing transfers meet quality standards and regulatory requirements, while implementing robust QA practices.

Qualifications

• 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.

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 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.

Skills

Risk assessments

Quality controls

Gage R&R

Supplier quality

Statistical analysis

DOE

Education

Bachelor's degree in Engineering or related field

Tools

PPAP

Process validation

MSA (Gage R&R)

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