|Job Type:||Full Time|
At TE, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable and more connected world.
- FDA, NB, Third Party audit coordination and support
- Internal auditor
- Quality reporting and Management review prep
- Medical CAPA, CCAR, RMA assistance, notifications, and trending
- Quality System Trending support
- Post market Surveillance support
- MDR vigilance reporting support
- Establishment registration
- Product listing
- Labeling support
- Regulatory submission support
- Front room scribe (for FDA)
- Standards upkeep and yearly revision audit
- Adhere to stated policies and procedures relating to health and safety, and quality management i.e. ISO and Corporate.
- Other duties as assigned by manager
- Must be US person or PRC holder due to access to products and technology controlled under the ITAR & EAR.
- Familiar with formal quality system assessments (i.e. ISO 9001, ISO13485:2016/MDSAP).
- Must be able to read and follow all written and implied directions, policies and procedures.
- Ability to analyze and resolve problems using various failure analysis techniques to isolate failures down to the root cause.
- Good organization, verbal, writing and listening skills.
- High level of attention to detail and accuracy.
- Work independently in a team environment.
- Must be proficient with Microsoft Office applications (Word, Excel, PPT, etc.).
EDUCATION & EXPERIENCE
- 2-year degree preferred
- 2-4 years’ experience in Medical Industry
- This individual must be self-driven, results-oriented with a positive outlook and a clear focus on quality.
- Comfortable in dealing with employees at all levels. Good communicator and customer friendly.
- Must be proficient in use of MS Office Excel, Word, Access, and PowerPoint.
- Good communication and computer skills, including data analysis and report writing skills