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Validation Engineer II
Ref No.: 17-02246
Location: Kalamazoo, Michigan
Start Date / End Date: 04/24/2017 to 04/23/2020
Job Title: Validation Engineer II
Duration: 36 months
Location: Kalamazoo, MI

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.
Please list out the (up to) top 3 critical 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.
How many years experience are required?: 3-5 years
What is the minimum education experience required?: BS