Facilitate product and process Corrective and Preventive Action (CAPA) investigations from issue identification through implementation of solution and effectiveness monitoring. Represent CAPAs during audits and CAPA Review Board meetings. Lead and mentor cross functional teams with the implementation of appropriate root cause analysis techniques (e.g. Pride problem solving).Analyze quality monitoring data sources and apply statistical techniques to identify existing and potential causes of non-conformances. Work effectively with all levels of management to ensure CAPA action plans can be supported and that costs/resources needed to implement the plan are available.
Questions to ask:
1. Experience and Background:
o What experience do you have with quality assurance and control processes in the medical device industry?
o Can you describe a time when you identified an issue in the production process that could have caused product defects?
2. Regulatory Knowledge:
o How familiar are you with the regulations and standards that apply to medical devices, such as ISO 13485 or FDA regulations?
o Have you ever conducted clinical trials or other research studies related to medical devices?
3. Problem-Solving and Analysis:
o Explain your understanding of root cause analysis and how it can be used to identify and address issues in the production process.
o What methods do you use to measure and monitor the performance of quality control processes?
4. Quality Management Systems:
o Are you familiar with any quality management systems such as ISO 9001 or Six Sigma?
o What strategies do you use to develop and implement effective quality control procedures?
We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to
HR@insightglobal.com.
To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy:
https://insightglobal.com/workforce-privacy-policy/ .
Bachelors degree plus a minimum of 5 years in the medical device or another regulated industry as a quality engineer or related
Understanding and application of global medical device regulations; FDAs 21 CFR 820, ISO 13485, EU Medical Device Directive (93/42/EEC), Canadian Medical Devices Regulation (SOR/98-282), Japanese MHLW Ordinance 169, ANVISA, ISO 14971, ISO 9001, and others including familiarity with the European Medical Device Regulation MDR 2017/745.
Experience in Quality Management System processes, including cross sector or business process standardization, ensuring effectiveness and efficiency while maintaining compliance with worldwide regulations
An ability to successfully communicate and educate Quality Management System regulations, policies and strategies to teams at all levels of the organization
Experience in corrective and preventive actions, including root cause analysis, documenting findings/actions, and implementing actions.
Advanced Analytical Skills; demonstrated ability to troubleshoot complex process/system issues
Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.