- Functional Area: Pharma / Biotech / Healthcare / Medical / R&D
- Industry: Medical & Health/Wellbeing Services
Job Title : Validation Engineer
Location : Kalamazoo, MI
Duration : 36 Months Contract
- 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.
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.
- Name: Mukesh Sharma
- Email: firstname.lastname@example.org
- Phone: 9525463300
- Extension: 6003
- Name: Select Source International
- Website: www.selectsourceintl.com