Quality Engineer II (1 opening)
Quality Engineer II (1 opening)
Posted on :
14-08-2025
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1 Vacancy
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Job Description
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
Minimum Requirements
Work Methodology:
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
- Bachelors degree in Engineering (completed) minimum3 years of experience in a regulated industry(medical device pharmaceutical or related manufacturing).
- or Masters degree in Engineering 1-2 years of direct related experience.
- 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 work100% on-site.
- 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-Villalba 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
Employment Type
Full Time
Key Skills
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