Sr Quality Engineer-New Product Introduction (Medical Devices)

Location: Juncos, Puerto Rico, United States of America

Company

hirify.global develops healthcare technologies intended to alleviate pain, restore health, and extend life.

What you will do

• Provide quality leadership and oversight for new product introduction from development through commercial launch.
• Partner with engineering and manufacturing teams to integrate quality requirements into products and processes.
• Lead continuous improvement, quality initiatives, validation, change control, and risk burndown activities.
• Design inspection, testing, and evaluation methods for products, equipment, and processes.
• Analyze quality data, investigate nonconformances, identify root causes, and implement corrective actions.
• Maintain quality documentation and support compliance with regulatory and internal quality system requirements.

Requirements

• Bachelor’s degree in Engineering and at least 4 years of relevant experience, or a master’s degree and 2 years of relevant experience, or a PhD.
• Experience in quality engineering within a regulated manufacturing or medical device environment.
• Experience applying quality tools and methodologies to investigations, corrective actions, and process improvements.
• Experience collaborating with engineering, manufacturing, and quality teams.
• Unrestricted U.S. work authorization is required at hire and throughout employment; sponsorship is not available for roles below Principal level.
• Foreign-earned bachelor’s degrees must satisfy the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A).

Nice to have

• Experience with Design Controls, Risk Management, validation lifecycle management, change control, reliability engineering, and product performance testing.
• Expertise with Minitab, Statistical Process Control, and trend analysis.
• Lean Six Sigma Green Belt or Black Belt certification.
• Experience leading cross-functional projects, influencing stakeholders, or mentoring engineers and project teams.

Culture & Benefits

• Purpose-driven work focused on healthcare technology and patient outcomes.
• Competitive compensation and a flexible benefits package.
• Eligibility for the hirify.global Incentive Plan short-term incentive.
• Reasonable accommodations are available for qualified individuals with disabilities.