The Product Quality Engineer develops and implements quality plans, metrics, programs, and procedures using quality control statistics, lean manufacturing concepts, and analyses and ensures that performance and product quality from internal Manufacturing and Contract Manufacturers conforms to established company, customer and regulatory requirements. Reviews, analyzes and reports on quality discrepancies related to assembly and process. Leads investigation of problems and develops dispositions, modifications, and corrective actions for recurring or non-recurring discrepancies. Interfaces with manufacturing, engineering, customer, vendor and subcontractor representatives to ensure requirements are met. Has primary responsibility for planning and implementing the positions key responsibilities as they apply to new product introduction.
WHO WE WANT TO ATTRACT:
* B.S. in a technical discipline is required. Advanced degree preferred.
* Five plus years of professional work experience.
* Willingness to travel up to 25% Domestic and International
* Certification in Quality Engineering/Auditing/Improvement, Six Sigma, Project Management, or Lean is a plus.
* Experience with IS0 13485 and Medical Device certification processes desired
RESPONSIBILITIES AND KEY FOCUS AREAS:
* Serves as the Quality lead and interface for products built at on site and at contract manufacturers. Leads the development, modification, and maintenance of quality evaluation, control plans and protocols for processing materials into partially finished or finished products.
* Manages assigned product failure analysis, report generation, and presents to customer.
* Leads problem solving teams utilizing 8D methodology.
* Leads cross functional team Corrective and Preventive Action (CAPA) activities to drive performance improvements.
* Assists in the process for ensuring that corrective actions (CAPA) are completed in accordance with relevant ISO requirements (ISO 9001), Advance Problem-Solving methods, and that documentation is complete and compliant with requirements.
* Conducts Data Analysis and prepares metrics detailing field product quality.
* Manages quality data for accuracy and report generation.
* Collect, treat and interpret data, analyze results using statistical techniques
* Identify, analyze and interpret trends or patterns in complex data sets
* Works with staff as necessary to enhance data capture and analysis in support of internal and external quality improvement and reporting efforts
* Serves as a resource for aggregating, analyzing, and displaying statistically oriented data
* Leads quality meetings with factory work cells.
* Supports factory process certification activities for new product introductions (NPI process).
* Leads the design and analysis of inspection and testing processes, mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine responsibility for, products or materials that do not meet required standards and specifications.
* Audits quality systems for deficiency identification and correction.
* May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.
* Support all company safety and quality programs and initiatives. Other responsibilities may be assigned from time to time as needed, and the requirements of the department/position.