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Actalent Sr Technical Writer & Doc Control - Medical Device!!! in Boston, Massachusetts

AMAZAING Opportunity to join a great team as a Technical Writer & Doc Control Specialist!!!

In this role is to perform all the write up for formal verification and validation testing, as well as product development studies. This includes plans, protocols, reports, and engineering summaries. Experience with the design control process and its deliverables is required. Candidates for this assignment should be familiar with GMP.

Additional Skills & Qualifications:

  • Bachelors required in engineering and/or writing, experience with medical device or combination product including a device required.

  • Related Experience: 2 to 5 years related Engineering experience required

  • Would require med device or drug experience; regulated environment

  • Change Orders experience, ECO and ECR Experience

  • Must be proficient in Microsoft Office Suite. Working knowledge of Minitab

Description:

In this role is to perform all the write up for formal verification and validation testing, as well as product development studies. This includes plans, protocols, reports, and engineering summaries. Experience with the design control process and its deliverables is required. Candidates for this assignment should be familiar with GMP.

Responsibility Breakdown:

• Develop and update process documentation including assembly procedures, test procedures, routers, travelers, BOMs, process flows, and process FMEAs.

• Assist engineering team to qualify develop Design Verification and Validation documentation (protocol and report), Gage R&R Studies, Process Capability Studies and Designs of Experiments and other technical documentation.

• Maintain accurate documentation of concepts, designs, and processes while maintaining current knowledge of medical and technical developments related to company products.

Skills:

technical writing, engineering, document control, design control, medical

Experience Level:

Expert Level

#LI-SC1

About Actalent:

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

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