What are the responsibilities and job description for the Quality Complaints Specialist position at Systems Ally?
NO C2C please
OPT stem OPT are welcome
What are the top 3-5 skills, experience or education required for this position:
- Masters in biomedical engineering
- Relevant educational experience or work experience in pharmaceutical field or product complaint field.
- Critical thinking, critical reading, and clear communication skills.
- Experience with the Microsoft suite of business programs (Outlook, Excel, Teams, PowerPoint, Word, etc).
- Ability to focus and prioritize work tasks.
Qualifications:
- Knowledge of global regulatory requirements for pharmaceutical, medical devices and combination products.
- Knowledge of FDA requirements for Quality Systems, pharmaceutical products, and Medical Device Reporting regulations (21 CFR 803, 820 and 211) is preferred.
- Ability to prioritize multiple projects to ensure compliance with regulations and standard operating procedures is preferred.
- Solid written/verbal communication and organizational skills.
- Knowledge and application of computer systems for word processing and complaint management.
- Ability to work with cross-functional teams and to interact effectively with peers, management, and customers.
- A Bachelor Degree required. Preferred degree in technology or scientific background (MLT, LPN, RN).
- 0-3 years’ work experience in a cGMP related industry or in a clinical setting is preferred