Validation Engineer

By Select Source International Posted On 03/20/2017 Kalamazoo, Kalamazoo County, Michigan, United States
3 - 5Years Job Type: Contract Joining Time: Immediate
Hourly Rate: USD 30 - 40 / Hour
  • Education: 
  • Functional Area:  Pharma / Biotech / Healthcare / Medical / R&D
  • Industry:  Medical & Health/Wellbeing Services
KEY SKILLS:  validationmedical13485

Job Description

Job Title               :          Validation Engineer

Location               :          Kalamazoo, MI

Duration              :          36 Months Contract

 

Job Description:

- Coordinate the updating and contemporization of the design history file documentation of a variety of products (Type 1 and 3 devices, convenience kits, and combination products) with the support of a multi-disciplinary team to meet current ISO 13485 and EU MDD regulatory requirements.

- Support design history file documentation of new products.

- May include quality systems set-up and maintenance for these products.

 

Top 3 Skills:
-Demonstrated knowledge of Medical Device guidances (e.g., ISO 13485, ISO 14971, MDD 93/42/EEC).

-Previous experience with writing Design History File documentation and remediation, and Process, Design and User FMEAs.

-Understanding of cGMPs, regulatory compliance, and industry quality assurance practices and systems.

-Able to work independently and coordinate the input from a multi-disciplinary team.

About Company

Select Source International is a Global Solutions provider of IT staffing and Project services. Our service offering has 5 main practices; ERP, Application Development, Middleware, Database Management and Project Services. SSI offers industry leading Data Migration, Compliance, and Risk Management through its subsidiary Data Wave. Data Wave offers Cyber Security and risk management through a GRC product suite called Risk Utilities. In addition to our technology offerings, SSI also provides administrative and business consulting services. Industry Experience: Retail Healthcare Manufacturing Energy and Utilities Government Financial Engineering.

Recruiter Details

  • Name: Mukesh Sharma
  • Email: mukeshs@selectsourceintl.com
  • Phone: 9525463300
  • Extension: 6003

Company Detail

 

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