Vacancy expired!
job summary:
Our client is looking for someone with creativity, passion and experience; this person for a fully remote client-facing Quality Engineering role. An ideal candidate will have:- 13+ years of in-depth Quality System Implementation in compliance with FDB, FDA, and ISO 13485.
- 8+ years of multiple simultaneous project QA or client-facing QA consultancy.
- Experience with the R&D lifecycle with emphasis on the QA aspects.
- Knowledge of statistics and application of statistical methods
- Experience using Microsoft Access, Word, Excel, PowerPoint, Microsoft Outlook, and SolidWorks
- Experience in a medical device company is desirable. Understanding of US FDA Quality System Requirements, ISO/EN 13485:2003, and MDD requirements is desirable.
- Quick to learn.
- Positive, results-oriented, and energetic team player.
- Excellent analytical and problem solving skills.
- Excellent interpersonal and communication skills.
- Ability to work independently and collaboratively.
- Ability to prioritize and manage to critical project timelines in a fast-paced environment. Must be able to handle multiple responsibilities concurrently.
- Must be organized, have an eye for detail, and be able to put ideas into a tangible form.
- Logical and organized thought pattern.
- Ability to follow established policies and procedures and comply with regulatory requirements.
- Ability to deal with unresolved situations, frequent changes, delays, or unexpected events.
- Ability to point out issues so that they can be appropriately addressed.
- Experience level: Experienced
- Minimum 5 years of experience
- Education: Bachelors (required)
- Quality Management (4 years of experience is required)
- ISO 13485 (4 years of experience is required)
- 21 CFR 820 (4 years of experience is required)
- Med Device (4 years of experience is required)
- Windows
- CQE, RAB, or RAC Certification
Vacancy expired!