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Engineer II

Saint Paul, MN 55114

Posted: 04/07/2025 Employment Type: Contract Job Category: Engineering Job Number: 618701 Is job remote?: No Country: United States

Job Description


Target Pay Rate: 30-34.39/hr **salary will be commensurate with experience 

Job Description:

As a Quality Engineer, you will provide Quality Engineering support to manufacturing and new product development teams through Engineering Investigations, Qualifications and Validations. In this role you will identify quality issues, participate in quality improvement projects and quality activities that impact manufacturing. Additional responsibilities will include maintenance of on-going stability validations, nonconformance investigations, maintenance of risk management documentation, and corrective and preventive actions when required. What you'll be doing:
  • Responsible for NCR and CAPA activities. Investigate and disposition nonconforming material reports (NCR events). Initiate, investigate, and implement corrective and preventive actions as assigned. Perform internal quality system and supplier audits, as assigned.
  • Responsible for preparation of written Engineering Investigation, Qualification and Validation plans, statistical analysis of data and preparation of reports to support manufacturing improvements, on-going validations, and new product development efforts.
  • Support product development teams to develop new products and transfer to manufacturing through participation/leadership of risk management activities, performance of component qualifications, and execution of test protocols.
  • Responsible for coordination of validation activities performed by outside contract services to ensure adherence to specifications and expectations.
  • Initiate documentation or documentation changes (DCRs, Deviations, etc.) for products and processes as required to reflect validation/qualification activities and results.
  • Other duties as assigned.

What you'll bring: Required
  • Experience managing non-conformance activities and owning corrective and preventative actions.
  • Must have the ability to read/interpret design prints.
  • Working knowledge of FDA GMP and ISO 13485 requirements.
  • Knowledge of statistics and quality tools such as SPC, Risk Analysis, Process Capability, DOE, TQM methods, and Lean/Six-Sigma.

Preferred:
  • Sterilization and Process Validation experience.
  • ASQ Certification in Quality Engineering.
  • Previous Quality System auditing experience.

Education and/or Experience:
  • BS in Engineering or related field of science.
  • 1+ years of experience in Manufacturing Quality, Design Assurance or Quality Systems.

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma is an equal opportunity employer. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Saint Paul, MN

Explore exciting job opportunities in the vibrant area around Saint Paul, Minnesota! Known as the 'Twin Cities' area along with Minneapolis, Saint Paul offers a dynamic job market with ample room for growth and development. Considered the state capital, Saint Paul boasts a unique blend of historic charm and modern amenities. From the iconic Cathedral of Saint Paul to the bustling Saint Paul Farmers Market, there is always something to discover in this culturally rich city. With renowned art galleries like the Minnesota Museum of American Art, world-class theaters such as the historic Fitzgerald Theater, and beloved sports teams like the Minnesota Wild hockey team calling the Xcel Energy Center home, there's no shortage of entertainment options. Embrace the Midwest's warm hospitality and endless outdoor activities in beautiful parks like Como Park and the Mississippi River trails. Let's kickstart your career in this thriving and enchanting region – browse our job listings today!

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.