Manufacturing Quality Engineer - Medical Device
Manufacturing Quality Engineer - Medical Device
Intellectt Inc
Saint Paul Church, MN
See who Intellectt Inc has hired for this role
Role: Manufacturing Quality Engineer
Location: West Valley City, UT - 84119
Duration: 12 Months on W2
ONSITE Interview
Job Description
Flexible Work Model - HM wants this candidate on site for executions and at the beginning. Then there will be an opportunity for this worker to work remotely a few days a week
Location: West Valley City, UT - 84119
Duration: 12 Months on W2
ONSITE Interview
Job Description
Flexible Work Model - HM wants this candidate on site for executions and at the beginning. Then there will be an opportunity for this worker to work remotely a few days a week
- EUMDR Special Project
- The position will need to help execute gap assessments against EUMDR. So preferably candidates who are more familiar with that standard would be the preference. The individual should still have a strong validations background as well. After the gap assessment, the validations will take place.
- Generation and execution of validation plans, validation protocols (IQ/OQ/PQ), and completion reports, with a major focus on Test Method Validation and EUMDR Validation Remediation of medical devices.
- Provide statistical analysis of the date to support the reports.
- Troubleshooting equipment/processes that do not perform as intended during validation runs.
- Recommend process/quality improvements as part of validation runs.
- Evaluate, investigate and document non-conformances incidents and/or protocol deviations.
- Complete assigned Non-Conformance and CAPA investigations and prepare investigation reports.
- Develops and maintains an effective cross-functional working relationship with plant and corporate Manufacturing, Engineering, Regulatory, and Quality Assurance personnel.
- Work on project teams with other internal departments, external vendors, and customers as required.
- Assure that existing processes and assigned activities fully comply with regulatory and/or international agencies, such as FDA, ISO, OSHA, EPA, among others.
- Participate in the compilation and review of technical documentation for both domestic and international regulatory submissions.
- Participate in external audits such as: FDA, Notified Body (BSI) and Corporate, among others. Performs other related duties as necessary.
- Knowledge of FDA, OSHA, EPA, and GMP and ISO requirements. Knowledge in Organizational Excellence and Lean/Six Sigma.
- Strong Project Management skills. Ability to lead teams through complex projects and provide departmental technical leadership.
- Must have excellent communication skills and a strong track record of working cross-functionally.
- Must have demonstrated the ability to think strategically.
- Able to develop technical documentation such as: Change Controls, Validation Plans, Validation Protocols, Technical / investigation reports, SOP, and others.
- BS in Engineering, preferably Mechanical, Manufacturing, Industrial, Electrical, Chemical, or Biomedical (Professional Engineer License.) or sciences related field.
- Lean/Six Sigma Green or Black Belt Certification is a plus.
- Experience in validations such as: manufacturing equipment, manufacturing processes, Test Method validation, stability or aging, required.
- Minimum of 4-6 years of experience in the medical device and/or pharmaceutical manufacturing environment.
-
Seniority level
Entry level -
Employment type
Contract -
Job function
Engineering and Information Technology -
Industries
Medical Equipment Manufacturing and Biotechnology Research
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