Quality Engineer - Contract - Alameda, CA
Proclinical is seeking a dedicated and innovative Quality Engineer for medical device products.
Primary Responsibilities :
The successful candidate will work both independently and collaboratively to develop and validate new products that will revolutionize the field of medical diagnostics.
The primary focus of this role is the design and creation of new medical device products.
Skills & Requirements :
- Bachelor's degree in engineering or another related field.
- Experience in product design and development.
- Proven working experience with manufacturing and design transfer.
- Hands-on experience with nucleic acid amplification techniques, immunoassay tests and lateral flow assays.
- Strong knowledge of quality engineering for medical devices and IVDs.
- Familiarity with FDA and EU regulations.
- Understanding of the Quality Management System life cycle.
- Excellent communication skills.
- Ability to coordinate the execution and documentation of Design Validation and Verification activities.
- Familiarity with Risk Based Approach to processes.
- Good working knowledge and application of validation and statistical techniques.
- Understanding of ISO 13485, ISO 14971, 21 CFR part 820, IEC 61010, IEC 60601 and Quality System Regulations with a focus on Design Controls and Risk Analysis.
- Experience with manufacturing and design transfer is preferred.
The Quality Engineer's responsibilities will be :
- Collaborate with a team of engineers to ensure the development of high-quality processes and products.
- Manage both large and small projects across the engineering team.
- Document internal processes and protocols and generate accurate reports for all tests.
- Use engineering knowledge to provide solutions to challenging problems.
- Communicate with suppliers on a technical basis to ensure product quality.
- Develop solutions for internal and external tests to determine product quality and supporting equipment.
- Learn new software quickly and produce meaningful results.
- Manage multiple tasks and prioritize effectively with limited oversight.
- Improve test stands and fixtures.
Compensation :
$50 - $55 per hour
If you are having difficulty in applying or if you have any questions, please contact Anderson Maldonado on a.maldonado@proclinical.com .
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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