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SoloPoint Solutions, Inc.
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60.
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Quality Engineer
2024-06-28
2024-08-09
Employment Type:
Contract
Category: Quality Engineer
Job Number: 10034
Pay Rate: $55/hr. - $60/hr.
Job Description
Qualifications:
- 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
- Quality Systems expertise including document control, CAPAs, NCMRs, change order management
- Cross-functional experience with product development/R&D, operations, suppliers
- Hands on approach with excellent communication skills
- Equipment and vendor qualifications
- 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
Responsibilities
- Support a team of engineers to ensure the development of quality processes and products
- Oversee Quality Management System including managing change orders, Non-Conformance reports, CAPAs
- 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