Sr Quality Engineer (Medical Devices)

Location: Humacao, Puerto Rico, United States of America; onsite role

Company

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

What you will do

• Lead quality engineering activities for machining, anodizing, final packaging, and related manufacturing processes.
• Partner with Manufacturing, Process Development, Engineering, Supply Chain, and Quality teams to establish and sustain effective quality controls.
• Develop inspection, testing, validation, and process evaluation methods for equipment, components, and products.
• Apply statistical analysis and quality engineering tools to assess process capability, investigate deviations, and support qualification.
• Support product lifecycle quality activities, including incoming materials, product evaluation, change management, nonconformance, CAPA, and continuous improvement.
• Prepare technically justified, risk-based, compliant, and audit-ready investigations, validations, corrective actions, and quality documentation.

Requirements

• Bachelor’s degree in engineering and at least 4 years of relevant experience, or a master’s degree in engineering and at least 2 years of relevant experience, or a PhD with no experience requirement.
• Experience in regulated manufacturing, preferably medical devices, pharmaceutical, or another highly controlled industry.
• Working knowledge of quality systems, documentation, nonconformance handling, CAPA, change control, risk assessment, and audit readiness.
• Ability to support manufacturing process quality activities, investigations, validation deliverables, and product or process performance monitoring.
• Unrestricted U.S. work authorization is required at hire and throughout employment; sponsorship is not available for roles below Principal level.
• For degrees earned outside the United States, the engineering degree must meet the applicable U.S. regulatory requirements stated in the posting.

Nice to have

• Mechanical, Industrial, or Electrical Engineering education and medical device experience.
• Knowledge of ISO 13485, FDA Quality System Regulation, GMP, validation concepts, URS, SRS, IQ, OQ, PQ, and inspection readiness.
• Experience with machining, anodizing, final packaging, component qualification, SPC, capability analysis, DOE, trending, and sampling rationale.
• Experience with root cause analysis and risk tools such as 5 Whys, Fishbone, FMEA, or fault tree analysis.
• Experience with Minitab, JMP, advanced Excel, Power BI, SAP, JDE, Factory Works, VBA, Python, or AI tools for reporting and process analysis; Lean Six Sigma certification is preferred.

Culture & Benefits

• Full-time employment within a global healthcare technology organization.
• Competitive salary and flexible benefits package.
• Eligibility for the hirify.global Incentive Plan short-term incentive.
• Reasonable accommodations are available for qualified individuals with disabilities.