- Write and maintain technical documents such as Standard Documentation, Work Instructions, and Implementation plan for lab equipment and personnel as deemed necessary by the Quality Team.
- Generate and implement Continuous Improvement and Best Practice policies.
- Implement lab equipment and quality software by creating a planning process that maintains integrity and requirements of the Quality Lab and personnel.
- Participate in print reviews to confirm the scope of a metrology event, confirm all necessary information is correct and available, and qualification requirements are met.
- Review and provide feedback on customer specifications.
- Sort, analyze, and interpret metrology data results as feedback to project team on process performance.
- Utilize data results to make decisions on next steps.
- Prepare Development and Qualification protocols and reports for project team and customer review.
- Define, plan, review, and approve Metrology System Analysis (MSA) requirements as it relates to the measurement of a specified part.
- Assist with Gage Repeatability and Reproducibility (GR&R) Studies.
- Assist with development of customized Metrology Systems according to MGS and Customer requirements and standards.
- Read, comprehend, and interpret engineering drawings and specifications.
- Review and interpret Geometric Dimensioning and Tolerancing (GD&T).
- Maintain a basic knowledge of manual inspection gages including, but not limited to, Calipers, Height Gages, Pin Gages, etc. for part verifications and measurements.
- Create and maintain part specific documentation during the Development process.
- Assist with troubleshooting Metrology System errors and variability.
- Develop, perform, and analyze First Article Inspections.
- Generates, communicates, and implements ideas and solutions.
- Demonstrates accuracy and thoroughness in completing tasks timely.
- Looks for ways to improve and promote quality.
- Know and follow all of the Company's safety rules, such as safe work practices and standard operating procedures.
- Serve as a good role model to employees for safe work practices and behavior by conducting yourself professionally, keeping in mind your own safety and the safety of others.
- Learn and master all necessary areas of the quality system.
- Follow Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
- Any other duties as assigned.
- Completion of an accredited four-year university program in Mechanical Engineering, or in a related field of study
- 3-5 years of experience, or accrued on-the-job experience and training is required
- Working knowledge and application of Geometric Dimensioning and Tolerancing (GD&T)
- Experience within the metrology scope, troubleshooting, software applications used in programming and data acquisition activities is recommended.
- Working knowledge with Solidworks, Creo, Calypso, PCDMIS, Minitab, and other quality related software is a plus.
- Good understanding and ability to perform tasks and create documents using Microsoft Office products.
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Validation Engineer - Germantown, United States - MGS Mfg. Group
Description
Job DescriptionMGS has an exciting opportunity for a Validation Engineer to join our MGS Germantown team.
As a Validation Engineer at MGS, you are responsible for verifying all transferred product to MGS meets the form, fit, and function requirements and is suitable for the manufacturing environment.
Below are additional duties and responsibilities:
As a global provider of healthcare manufacturing solutions, MGS provides the right balance to drive vital innovations: robust end-to-end solutions combined with the strong customer focus and seamless collaboration of an agile partner. That's why we're the engineering and manufacturing partner of choice for today's leading Pharma, Diagnostic and MedTech innovators. Serving customers from 12 strategically located facilities around the world, we transform our customers' most pressing challenges into innovations that improve lives. To learn more about MGS, please visit
Experience and Skills
A qualified Validation Engineer candidate would fulfill these requirements:
We offer an excellent benefits package including medical, dental, vision, 401K, disability, life, FSA, vacation, and holidays.
