Senior Quality Engineer
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Job Location:
Juana Diaz - USA
Monthly Salary:
Not Disclosed
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
For Project Management services in the Manufacturing area.
WHAT MAKES YOU A FIT:
The Technical Part:
- Bachelors Degree in Engineeringor Sicence and five (5) years of experience inof theMedical Device or Pharmaceutical Industry.
- Bilingual: (Spanish and English)
- Soft Skills: Problem solving and effective persuasion skills.
- Shift: Administrative and according to business needs.
- Experience in:
- Manage all aspects of projects(s):planning implementation monitoring completion and follow-up.
- Proficient in Microsoft Excel data migration and Microsoft Word and PowerPoint.
- Product Transfer Injection molding and New Tooling.
- Quality Systems (CAPAs FMEAs Risk Assessments Supplier Qualifications Quality Audit and Non-Conformance Reports).
The Personality Part:
- Our Next Piece is someone who treats everyone they meet like family especially our resources clients and team other words being a customer service pro is one of your (many) talents. Being the Piece means youre full of bright ideas and eager to innovate always bringing top-quality results to the table. Are you ready to Be The Piece
AS A PIECE OF FITS YOU WILL: (The day-to-day on the job)
- Lead and support quality investigations including NCRs complaints and quality feedback ensuring proper root cause analysis and resolution.
- Develop implement and monitor Corrective and Preventive Actions (CAPA) to prevent recurrence of quality issues.
- Evaluate and analyze manufacturing and QA quality reports to identify trends risks and improvement opportunities.
- Monitor and report Quality KPIs (e.g. First Pass Yield DPM CPM) and drive initiatives to improve process performance.
- Support validation activities including protocol development execution deviation management and final reporting (IQ/OQ/PQ).
- Develop review and approve quality and engineering documentation such as SOPs procedures rework protocols and validation documentation.
- Participate in product and equipment transfers ensuring manufacturing readiness documentation compliance and successful startup.
- Lead and support continuous improvement and process optimization initiatives across manufacturing and quality systems.
- Conduct audits lot document reviews and process monitoring activities to ensure compliance with regulatory and quality system requirements.
- Ensure compliance with Quality System Regulations (QSR) GMP safety policies and regulatory standards while supporting training and quality.
WHO WE ARE:
We are a Service Provider company different from the rest. We pride ourselves in how we treat the most important piece of our companys puzzle: you! We integrate Engineering Construction Maintenance Utilities and Specialized Technical services across the Island (and in the US as well!). Our company is flexible family-oriented and focused on our resources well-being while providing our Pharmaceutical Medical Device and Manufacturing industryclients with top-notch quality talent.Were FITS!
Are you the Next Piece
Required Experience:
Senior IC
Key Skills
- Quality Assurance
- Six Sigma
- Design Controls
- FDA Regulations
- ISO 9001
- Minitab
- Root cause Analysis
- ISO 13485
- Quality Systems
- Quality Management
- As9100
- Manufacturing
