Supplier Quality Engineer
Supplier Quality Engineer
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Salary Not Disclosed
1 Vacancy
Job Description
Responsibilities:
- Process Validation and IQ-OQ-PQ Experience in medical parts manufacturing experience is the key with process validation expertise around 8 to 10 yrs experience.
- Protocol Review & Compliance: Study and assess Installation Qualification (IQ) Operational Qualification (OQ) and Performance Qualification (PQ) protocols and reports for regulatory and procedural compliance.
- Process Audits & Documentation: Conduct thorough audits of manufacturing processes to identify documentation gaps. Update Quality Management System (QMS) documents to reflect findings and ensure alignment with current standards.
- Process Optimization: Design and execute Design of Experiments (DoE) to optimize process parameters for CNC Machining and DCM. Establish and document robust process parameters and operating windows.
- Validation Execution: Execute or re-execute validation protocols including sample measurements and data collection. Generate comprehensive IQ OQ PQ reports based on validation activities.
- Statistical Analysis: Run statistical reports to analyze process capability variability and performance trends.
- Change Management: Lead and document change management activities related to process improvements and equipment modifications.
- Continuous Monitoring: Monitor validated process parameters to ensure equipment and processes remain in a validated state. Implement controls and corrective actions as needed to maintain compliance.
- Experience working in QMS and ERP systems.
- Experience with IQ/OQ/PQ/TMV preferred.
- Worked with cross functional teams.
- Collaborate with Quality Engineering to provide manufacturing support.
- Responsible for providing manufacturing engineering support to specific projects including change analysis risk analysis and manufacturing readiness.
- Should be experienced in medical device manufacturing assembly lines.
- Troubleshoot and resolve issues relating to the safety efficacy quality cost or delivery of components and finished devices.
- Need to conduct qualification verification and validation activities to produce medical devices.
- Need to be responsible for completing engineering work and contribute to new product development teams and product support typically including the following activities: technology development test of materials or products preparation of specifications six sigma process studies process improvements and report preparation.
- Participate on cross-functional project teams. Coordinate manage and document project work and progress and recommend appropriate revisions.
- Work with CFT teams in troubleshooting problems on the production floor.
Requirements:
- Bachelors or masters degree in mechanical engineering Biomedical Engineering or related field.
- 5 years of experience in medical device manufacturing with hands-on experience in CNC Machining and DCM.
- Strong understanding of FDA ISO 13485 and GMP requirements.
- Proficiency in statistical analysis tools (e.g. Minitab JMP).
- Experience with QMS systems and documentation practices.
- Excellent analytical problem-solving and communication skills.
Employment Type
Full-time
