Conde InduServices Corp.
Quality Engineer II (3 openings) Juncos, PR
Conde InduServices Corp., Juncos, Juncos, us, 00777
Summary
The Quality Engineer II will be responsible for supporting validation, risk management, and quality assurance activities in a regulated medical device manufacturing environment. This role requires expertise in validation protocols, statistical analysis, and regulatory compliance, with the ability to work cross-functionally with engineering, manufacturing, and quality teams to ensure product and process excellence.
Key Responsibilities
Develop, apply, and maintain quality standards and protocols for materials and products at various stages of production.
Collaborate with engineering and manufacturing teams to ensure quality standards are established and maintained.
Conduct compliant validation processes for equipment, manufacturing processes, and quality information technology systems, including URS, FAT, IQ, OQ, PQ, and TMV.
Review and approve validation test plans, reports, and deviations; perform statistical analysis to support validations and product release.
Devise and implement inspection and testing methods, procedures, and equipment to ensure product accuracy and compliance.
Investigate manufacturing events, defects, and rejects; analyze trends and recommend corrective and preventive actions (CAPA).
Lead complaint-handling activities in collaboration with operating unit members.
Maintain validation and quality documentation in compliance with applicable federal and international medical device regulations.
Perform system administration and configuration of quality information technology systems.
Prepare and maintain standard operating procedures (SOPs) for quality systems.
Verify and document the effectiveness of CAPA and non-conformance resolutions.
Coordinate with domestic and global stakeholders for compliance and quality improvement initiatives.
Report on validation activities to fulfill regulatory requirements.
Minimum Requirements
Bachelor’s degree in Engineering (completed)
Minimum
3 years of experience in a regulated industry (medical device, pharmaceutical, or related manufacturing) .
Experience with risk management documentation (pFMEAs).
Experience in process validation and equipment qualification (excluding cleaning processes).
Knowledge of URS, FAT, IQ, OQ, PQ, and TMV documentation (non-laboratory).
Basic to intermediate statistical analysis skills, preferably with Minitab.
Knowledge of defining validation strategies from design to manufacturing.
Knowledge of Good Manufacturing Practices (GMP) and medical device regulations.
Bilingual (English & Spanish – oral and written) .
Willingness to work
100% on-site .
Preferred Qualifications (Nice to Have)
Experience with design transfer activities and new product introduction projects.
Experience investigating manufacturing events and supporting product disposition.
Lean Six Sigma Green Belt Certification.
Experience in defect/reject trend analysis.
Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint, Outlook, Project).
Familiarity with systems such as SAP, Agile, Compliance Wire, Maximo, MRO Program, TEDS, HR – ABRA Suite, Gallup Online Tool.
Strong problem-solving and collaboration skills.
Availability to work overtime and weekends when necessary.
Work Methodology
Full time contract
100% on-site job in Medtronic-Juncos, PR
6 months of first contract with potential extensions based on performance and budget availability
Administrative shift with availability to work non administrative hours or weekends
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Key Responsibilities
Develop, apply, and maintain quality standards and protocols for materials and products at various stages of production.
Collaborate with engineering and manufacturing teams to ensure quality standards are established and maintained.
Conduct compliant validation processes for equipment, manufacturing processes, and quality information technology systems, including URS, FAT, IQ, OQ, PQ, and TMV.
Review and approve validation test plans, reports, and deviations; perform statistical analysis to support validations and product release.
Devise and implement inspection and testing methods, procedures, and equipment to ensure product accuracy and compliance.
Investigate manufacturing events, defects, and rejects; analyze trends and recommend corrective and preventive actions (CAPA).
Lead complaint-handling activities in collaboration with operating unit members.
Maintain validation and quality documentation in compliance with applicable federal and international medical device regulations.
Perform system administration and configuration of quality information technology systems.
Prepare and maintain standard operating procedures (SOPs) for quality systems.
Verify and document the effectiveness of CAPA and non-conformance resolutions.
Coordinate with domestic and global stakeholders for compliance and quality improvement initiatives.
Report on validation activities to fulfill regulatory requirements.
Minimum Requirements
Bachelor’s degree in Engineering (completed)
Minimum
3 years of experience in a regulated industry (medical device, pharmaceutical, or related manufacturing) .
Experience with risk management documentation (pFMEAs).
Experience in process validation and equipment qualification (excluding cleaning processes).
Knowledge of URS, FAT, IQ, OQ, PQ, and TMV documentation (non-laboratory).
Basic to intermediate statistical analysis skills, preferably with Minitab.
Knowledge of defining validation strategies from design to manufacturing.
Knowledge of Good Manufacturing Practices (GMP) and medical device regulations.
Bilingual (English & Spanish – oral and written) .
Willingness to work
100% on-site .
Preferred Qualifications (Nice to Have)
Experience with design transfer activities and new product introduction projects.
Experience investigating manufacturing events and supporting product disposition.
Lean Six Sigma Green Belt Certification.
Experience in defect/reject trend analysis.
Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint, Outlook, Project).
Familiarity with systems such as SAP, Agile, Compliance Wire, Maximo, MRO Program, TEDS, HR – ABRA Suite, Gallup Online Tool.
Strong problem-solving and collaboration skills.
Availability to work overtime and weekends when necessary.
Work Methodology
Full time contract
100% on-site job in Medtronic-Juncos, PR
6 months of first contract with potential extensions based on performance and budget availability
Administrative shift with availability to work non administrative hours or weekends
#J-18808-Ljbffr