Quality Assurance Specialist

3 days ago


West Boylston, Massachusetts, United States Coghlin Companies Inc Full time
Job Title: Quality Assurance Specialist

Cogmedix, a subsidiary of Coghlin Companies Inc., is seeking a Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of our products and services. This includes working with suppliers to identify and resolve quality issues, implementing quality-related programs and projects, and serving as a liaison between suppliers and Cogmedix operations.

Key Responsibilities:
  • Provide technical support to internal customers and suppliers for activities related to supplier quality system assessment, performance evaluation, and supplier development.
  • Responsible for supporting Supplier Development initiatives for current and new potential suppliers and for implementing quality-related programs and projects.
  • Identify supplier non-conformance trends and track supplier quality performance measurements for strategic suppliers.
  • Lead supplier visits, audits, and source inspections, and support and enhance the supplier selection and certification processes.
  • Collaborate with suppliers on inspection requirements and methodologies and reporting of inspection results to Cogmedix.
  • Drive suppliers to identify appropriate quality assurance systems that will ensure receipt of defect-free components/materials.
  • Champion the MRB process for supplier-caused defects and communicate identified issues and drive corrective action and preventive actions by the suppliers.
  • Support the new Scaled Product Launch development process as necessary and support/coordinate quality requirements between Cogmedix and suppliers as necessary.
  • Maintain current knowledge of relevant technologies, materials, equipment, and processes, and develop and maintain an understanding of industry and market trends and competition.
  • Develop, deliver, and ensure in-house training programs for company personnel in order to ensure regulatory compliance.
  • Drive improvements in suppliers' quality performance and develop quality metrics to evaluate supplier performance.
  • Support supplier quality management programs such as supplier selection and certification, manage, track, and trend all supplier corrective actions requests, and drive resolution of supplier corrective action requests.

Requirements:
  • Positive attitude, well-organized, self-motivator, and tenacious follow-up required.
  • Superior customer service attitude.
  • Excellent teamwork in various disciplines and on multi-functional teams, communication, and interpersonal skills.
  • Bachelor's degree, preferably in a science or engineering discipline, or significant and applicable professional experience may be considered in lieu of certain educational requirements.
  • Strong electro-mechanical and opto-mechanical orientation preferred.
  • Experience in ISO-13485 certified environment and cGMP organizations preferred.
  • Proven analytical and problem-solving skills.
  • Knowledge of IPC 610 and 620 standards beneficial.
  • Advanced Level Skills in MS Word and Excel, such as keyboard shortcuts, creating macros and forms, table techniques, working with images and text, pivot tables.
  • Advanced Level Skills in MS Visio, such as creating Visio diagrams, creating custom styles and templates, cross-functional flow charts, linking drawings to other MS applications, working with data, custom reports, and exporting.
  • 5 years in medical subassembly and finished device manufacturing supplier quality or supply chain management preferred and/or engineering that included driving supplier performance improvements and/or meeting and organization's needs.
  • Demonstrated understanding of Statistical Process Control (SPC) and experience implementing SPC or similar controls.
  • Experience with molded plastics, sheet metal, cables and wire harness, PCB's, electronics, and machined parts desirable.
  • Six Sigma certified desirable.

Physical Requirements:
  • Standing for prolonged periods of time.
  • Lifting up to 30 pounds.

Cogmedix is an Equal Opportunity Employer.

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