Qualification: BS in Engineering and 2 years’ experience working in product design and development Strong knowledge of quality engineering for medical devices and IV - Ds Familiar with FDA and EU regulations Understanding of the Quality Management System life cycle Hands on approach with excellent communication skills Equipment and vendor qualifications Coordinate the execution and documentation of Design Validation and Verification activities. Manage and keep up to date Design History Files and... more details
Qualification:
BS in Engineering and 2+ years’ experience working in product design and development
Strong knowledge of quality engineering for medical devices and IVDs
Familiar with FDA and EU regulations
Understanding of the Quality Management System life cycle
Hands on approach with excellent communication skills
Equipment and vendor qualifications
Coordinate the execution and documentation of Design Validation and Verification activities.
Manage and keep up to date Design History Files and Medical Device Files for products.
Familiar with Risk Based Approach to processes.
Demonstrate good working knowledge and application of validation and statistical techniques to comply with associated regulatory requirements and internal standards
ISO 13485, ISO 14971, 21 CFR part 820, IEC 61010, IEC 60601 and Quality System Regulations understanding with a focus on Design Controls and Risk Analysis
Hands on experience with nucleic acid amplification techniques, immunoassay tests, and lateral flow assays
Primary Responsibilities
Support a team of engineers to ensure the development of quality processes and products
Able to work on large and small projects across the engineering team
Manage and document internal processes and protocols and generate accurate reports for all tests
Utilize engineering knowledge to provide solutions to challenging problems
Communicates with suppliers on a technical basis to ensure a quality product
Create solutions for internal and external tests to determine the quality of the product and supporting equipment
Able to quickly learn new software and output meaningful results
Comfortable working with some ambiguity on early-stage development
Hands on self-starter with strong time management skills
Communicates effectively with cross functional teams and within group
Ensure quality on consumables with sample preparation and microfluidics for IVD applications
Manage multiple tasks and prioritize effectively with limited oversight
Use and improve test stands and fixtures
Must be self-motivated and able to work in a fast-paced environment
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