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Quality Engineer
Job Description
Our client is a medical products manufacturer located in Oxford, CT, have been in business since 2007 and have been continuing to grow ever since! They manufacture package and sterilize foam pads, bandages, IV tubes among other medical products. The IV tubes are specially made so that they can be heated up by EMT's while rushing to save someone, and have a great success rate in saving people when they have huge losses of blood. With a team of over 30 employees, they are growing and seeking a Quality Engineer in the Medical Device space!
Why Work Here?
Schedule:
Mon - Fri
7: 30 AM - 4: 00 PM (hours can be flexible)
Pay Rate:
$75K - $90K
IND-123
Why Work Here?
- Strong PTO plan and benefits + 401K.
- 70% Employer paid medical.
- Develop and execute monitoring methods to support product Quality, identify opportunities, Assess Risk, address / resolve opportunities found.
- Ensure QIP work instructions and NC Procedures are followed and actions documented Properly.
- Ensure products are manufactured following CMM & industry Quality Standards.
- Control of Non-conforming product following 2830.1.
- Products and parts reworks and deviations are developed and executed based on risk and customers are notified accordingly.
- Corrective and Preventive Actions identification, plan, implementation, and closure
- Analyze Customer Complaints, identify root causes and implement actions when required.
- Monitor Sterile Product Yields
- Assess / Release Sterilization Records from sub-contractor for accuracy (Training Required)
- Verify shipping documentation, approve CofC and Approve for shipment to customer of Sterile Product
- Investigate EO excursions and provide Risk Assessment and disposition justification. Document assessment, corrective action and dispositions as required. (Training Required)
- Initiate activities and Collaborate with Engineering to get resolution of problems identified.
- Assess First Pass Yield Data, Identify and assess Gaps, drive resolution to quality Processes,, and submit Manufacturing Processes gaps found to Engineering to get resolution of them.
- Ensure good metrology procedures are in place and ensure every user understand how an instrument is properly used to obtain reliable results during inspections.
- Ensure drawings and attribute charts are accurate,
- Monitor Sterilization Processes for Compliance
- Assess and document Annual Reviews as per schedule –Q1-YYYY
- Coordinate / execute Validations of current cycles on time.
- Assess changes and evaluate and document impact in the sterilization process. Identify actions and follow through until implementation.
- Implementation and monitoring of product bioburden programs for sterile products. Perform annual reviews, monitor trends, identify opportunities for improvement and actions to close opportunities found.
- Assess effectiveness of Environmental Monitoring Program and Document Annual reports (Viable / Non-Viable)
- Monitor and manage the EM program for ECA’s and Pre-Sterile Products. Assess and approve Reports for NV Particle Counts. Document and approve results for Viable counts of EM & Product Bioburden.
- Also responsible for continued process improvement, and making sure all standards are met.
- Handle non conforming product / supplier quality. Will need to work with suppliers to understand if engineering processes need to be changed with certain products.
- 2-3 years of Quality Engineering experience.
- Medical device industry experience or airline industry experience.
- Six Sigma and Lean Principles.
- Experience with quality systems.
- Solid works and CAD exp is a major plus.
- Troubleshooting + root cause analysis experience.
- Able to draw blueprints.
Schedule:
Mon - Fri
7: 30 AM - 4: 00 PM (hours can be flexible)
Pay Rate:
$75K - $90K
IND-123
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Ready to take the next step in your career? Explore job opportunities in the vibrant area around Oxford, Connecticut! Located just a short drive from New Haven, Oxford offers the perfect blend of small-town charm and big-city opportunities. With easy access to renowned landmarks like the Yale University campus, picturesque hiking trails in Southford Falls State Park, and the exciting theater productions at the Shubert Theatre, there's something for everyone in this enchanting region. Don't miss out on the chance to be part of a thriving community with a rich history, delicious local cuisine, and endless growth possibilities. Discover your dream job in the bustling area around Oxford today!