Find Jobs
Make your next engineering career move with SoloPoint.
So sorry, this position is no longer available.
Please go ahead and submit your application. We may have other positions that would be the perfect fit for you.
Alternatively, you may want to apply to one of the following related jobs:
SoloPoint Solutions, Inc.
https://www.solopointsolutions.com/wp-content/uploads/2021/05/JB-Square-200x200-1.png
https://www.solopointsolutions.com
https://www.solopointsolutions.com
USD
55.
60.
HOUR
true
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