Quality Assurance Specialist

1 day ago


North Haven, Connecticut, United States Tek Support Full time
Job Description:

As a Quality Engineer at Tek Support, you will play a crucial role in ensuring the highest quality standards are met in our manufacturing processes. Your primary responsibility will be to contribute to continuous improvements in overall product cost and quality.

Key Responsibilities:
  • Participate in Design for Manufacturing (DFM) and Design for Assembly (DFA) activities to ensure that packaging and production processes are optimized.
  • Collaborate with Quality Engineering teams to provide manufacturing support and ensure compliance with regulatory requirements.
  • Create standardized work and process maps to optimize production systems and extend value streams.
  • Support line validation and qualification activities, including IQ, OQ, MSA, and PQ.
  • Perform root cause analysis, non-conformance reports, and corrective action responses.
  • Conduct qualification, verification, and validation activities to produce medical devices.
  • Work with cross-functional teams to troubleshoot problems on the production floor.
  • Design, develop, test, and validate equipment and processes, and analyze and interpret process models to recommend improvements.
  • Drive the execution of validation and Process Failure Mode and Effects Analysis (PFMEA) activities.
  • Apply statistical and analytical methods, such as Statistical Process Control (SPC), Statistical Quality Control (SQC), and Design of Experiments (DOE).
  • Contribute to the Capital Expense Request (CER) process and specify costs for packaging, labeling, and sealing equipment.
  • Provide detailed engineering analysis and documentation for material disposition, process updates, non-conformance reports, and corrective action responses.
  • Execute site acceptance tests and factory acceptance tests.
  • Plan and initiate Change Disposition Processes (CDPs) associated with validation activities.
  • Coordinate with stakeholders to ensure effective communication and collaboration.
Qualification:
  • Minimum 3 years of applicable experience in packaging engineering, medical devices, pharmaceuticals, or a related industry.
  • Broad knowledge of Mechanical/Manufacturing Engineering.


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