Sr. Quality Systems Specialist for Medtronic, Inc. at its facility in Littleton, MA. Provides technical support to all areas of Medtronic by gathering, organizing and analyzing the data generated by the Corrective and Preventive Action (CAPA) system. Verify the implementation of the policies and procedures described in the documented quality system related to CAPA. Supports the MNL Quality System group and partners with stakeholders, to collaborate on Quality System alignment and improvement. Navigates the complexities or working in a medical device regulated field. Coordinates CAPA activities related to risk analysis processes and utilizes and Lean and Six Sigma processes. Participate in problem solving efforts to resolve recurring and new quality issues in order to ensure production of safe and effective medical devices. Provides various statistical analysis using statistical tools including Excel and Minitab. Develop, maintain and communicate metrics on CAPA system to ensure timely and accurate information. Conduct root cause investigations; document findings and provide reports and analysis. Recommend and implement corrective action and appropriate follow-up when necessary. Navigates various government and industry regulations to include FDA Quality System Regulation (QSR 21 CFR 820), Canadian Medical Device Regulation (CMDR), EU Medical Device Directive (EU MDD 93/42 EEC), JPAL and ISO 13485, ISO 14971 and ISO 17025.
Qualification & Experience:
- Masters’ degree in Biomedical or Mechanical Engineering and one (1) year experience with quality engineering and one (1) year of post-bachelor’s progressive experience in all of the following: In a quality assurance or quality control environment within a medical device regulated field; Continuous improvement projects through use of tools to include Lean, Six Sigma and Kaizen; FDA requirements for Corrective and Preventive Action (CAPA) Process; Statistical analysis using statistical tools including Excel and Minitab; Problem solving methodologies and root cause analysis; FDA Quality System Regulation (QSR 21 CFR 820), Canadian Medical Device Regulation (CMDR), EU Medical Device Directive (EU MDD 93/42 EEC), JPAL and ISO 13485, ISO 14971 and ISO 17025; Developing and tracking CAPA process metric to support improvement activities.
Vacancy Type: Full Time
Job Location: New Bedford, MA, US
Application Deadline: N/A