Vacancy expired!
- 5+ years as a Quality Engineer
- BS or MS: Engineering realm
- Regulated industry experience
- Some electromechanical device or system experience MUST- he does not want to see someone who has worked in molding. They have to be able to have worked with electronics.
- The Quality Engineer leads the Complaint Investigation Team and is responsible for ensuring root cause determination and ultimate resolution of product failures. Will work closely with Development and Operations and other functional areas to evaluate actual or potiential product failures and update risk
- Contributes to product safety, product quality, and customer satisfaction related decisions (both data based and risk-assessment-based decisions)
- Leads or participates and supports internal and external supplier audits and inspections
- Monitors and advises on how the product quality is performing and publishes data and reports regarding the effectiveness of the quality management system in achieving the product performance goals
- Plans and conducts the analysis, inspection, design, tests, and/or integration of test methods to assure the quality of assigned products or components
- Develops test methods and participates in the assessment of returned products, incoming, in-process and final test/inspection
- Coordinates the documentation review, inspection workflow, training, problem solving and calibration for products and test equipment
- Tracks and report quality metrics
- Advises on changes and their implementation and provides training, tools, and techniques to enable others to achieve quality
- Utilizes statistical analysis techniques to determine product acceptance and AQL sampling plans, evaluate process capabilities and develop statistically sound tolerance limits
- Participate in the non-conformance reporting system, driving timely disposition and closure. Leads and/or participates in MRB meetings, Identifies non-conformance trends and develop and administer technical investigation and corrective action programs to resolve recurring quality problems
- Contributes to the development and implementation of product test plans including Verification and Validation of products and processes
- Serves as liaison to design, procurement and manufacturing engineering
- Participates as a resource in validations applicable to processes and product
- Performs standard quality engineering reviews of design documentation for compliance with requirements
- May lead cross function teams in planning, analyses (dFMEA, FTA, Risk/Benefit) and mitigations
- Works with Manufacturing Engineering to address supplier quality issues
Vacancy expired!