An employer is looking for a Quality Engineer to join their Medical Device Manufacturing team. The QE will design, implements and maintains quality assurance protocols and methods for processing materials into finished products. Plans and manages the compliance of manufacturing and production processes with an internal and external safety, quality, and regulatory standard requirements. Develops methods and procedures for inspecting, testing, and evaluating of the precision and accuracy of production processes and equipment. Performs report and production data analyses to identify trends and recommend updates or changes to quality standards and procedures. Upholds the company's quality standards and testing systems to reflect efficiency, reliability, and performance. Creates documentation to report issues and errors relating to the production process.
- Evaluates product and process changes for qualification and validation requirements, and participates in change implementations
- Develops and implements inspection criteria and ensures inspections are performed by qualified personnel and that inspection results and documentation support the recommended disposition action
- Conducts investigations initiates and processes all necessary actions from quality system feedback such as records review, non-conforming materials reports, corrective action reports, complaints, and audit reports
- Leads Design Control activities such as risk assessment, supplier quality plans, design verification and validation, cleaning validations, and sterilization and packaging validation
- Identifies opportunities for improvement, and coordinates the development of criteria and documentation to facilitate the analysis and enhancement of various quality systems program elements * Liason with design team for NPI
* Designing processes through how product will be manufacturing
* Document and report issues for the production process.
* Seeing themselves a partner for operations
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.
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- Bachelor's degree in an Engineering Discipline (Biomedical, Medical, Quality, Mechanical, Aerospace, Manufacturing, Electrical, etc)
- 3-8 years of experience working in a highly regulated manufacturing environment (Medical*, Aerospace, or Automotive) - ISO and FDA
- Experience with Validation, Statistical Analysis, and Programming
- Experience working with a relevant ERP system: D365 (MS Suite) or similar program
- Experience with programming Data Analysis software: Python, or SQL
- Experience leading Design Control activities such as risk assessment, supplier quality plans, design verification and validation, cleaning validations
- Experience being audited by the FDA, BSI Audits
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.