Quality Engineer II - Medical Devices, CAPA & Validation

Medial Group; Juncos (PR); On-site; USD 70,000 - 100,000; Full time

Job summary

Medial Group in Juncos, Puerto Rico seeks a seasoned Quality Engineer to develop, modify and maintain quality standards for processes and products; collaborate with engineering and manufacturing to ensure quality standards are implemented and maintained.

Responsibilities include design of inspection methods, statistical analysis, validation activities (URS, FAT, IQ, OQ, PQ, TMV), PFMEA, Control Plans, and CAPA; regulatory knowledge (FDA, EU MDR) and 5+ years experience.

Qualifications

• Minimum 5 years of experience in the medical device/regulated industry (excluding laboratory).
• Bachelor degree in Engineering completed.
• Investigation and root cause analysis skills.
• Strong technical writing, organizational, and communication skills.
• Experience with risk management documentation (PFMEA).
• Knowledge in medical device regulations (FDA, EU MDR).
• Basic knowledge in statistics (preferably with Minitab).
• Experience in process validation and equipment documents: URS, FAT, IQ, OQ, PQ, TMV.
• Experience investigating and assessing manufacturing operations and defects/rejects trends.
• Ability to apply statistical techniques, develop/review/approve test plans and reports.

Responsibilities

• Develop, modify, apply, and maintain quality standards for processes and products.
• Collaborate with engineering and manufacturing functions to ensure quality standards are implemented and maintained.
• Design and implement methods and procedures for inspecting, testing, and evaluating products and production equipment.
• Perform statistical analysis to identify trends in defects/rejects and support decision-making.
• Ensure all documentation is compliant with regulatory and company requirements.
• Conduct and/or review validation activities (URS, FAT, IQ, OQ, PQ, TMV – excluding laboratory and cleaning processes).
• Investigate and collaborate in atypical events and CAPA to support product disposition.
• Develop and update PFMEA, Control Plans, and Process Flows.
• Support projects involving design requirements validation and manufacturing controls (not Operational Excellence).
• Other duties may be assigned.

Skills

Root cause analysis

Technical writing

Communication skills

Statistics (Minitab)

Risk management understanding

Education

Bachelor Degree in Engineering

Tools

Minitab

Microsoft Office

Job description

Medial Group in Juncos, Puerto Rico seeks a seasoned Quality Engineer to develop, modify and maintain quality standards for processes and products; collaborate with engineering and manufacturing to ensure quality standards are implemented and maintained.

Responsibilities include design of inspection methods, statistical analysis, validation activities (URS, FAT, IQ, OQ, PQ, TMV), PFMEA, Control Plans, and CAPA; regulatory knowledge (FDA, EU MDR) and 5+ years experience.