Website CYNET SYSTEMS
CYNET SYSTEMS
Company : CYNET SYSTEMS
Job Description:
Responsibilities:
- Represent the organization and Quality Department professionally.
- Support Project Teams and the Quality Department.
- Perform all product testing in the Complaint Laboratory.
- Provide technical support to resolve quality issues, including complaint reviews.
- Conduct complaint investigations for internal and OEM products.
- Create investigation files in the complaint system.
- Set up, safely operate, and maintain laboratory equipment and instruments.
- Conduct tests and experiments following GMP and GLP requirements.
- Develop and maintain knowledge of company policies, ISO requirements, and FDA regulations.
- Maintain accurate data, analyze results, and assist in concluding.
- Work in a biohazard environment and follow safety procedures.
- Ensure compliance with department and division procedures.
- Interface with manufacturing facilities, suppliers, and other internal groups.
- Present data findings to peers, engineering teams, and management when required.
Requirement/Must Have:
- Technical or Associate degree in a science-related field (preferred but not required).
- Prior laboratory experience preferred.
- Proficiency in MS Excel (pivot tables, V-lookup, etc.).
- 1 3 years of experience in a regulated industry (including co-op or internship).
Experience:
- Basic understanding of medical device regulations and industry standards.
- Experience with laboratory bench methods and equipment.
- Familiarity with OSHA requirements, QSR, GLP, ISO, AAMI, and FDA guidelines.
- Ability to interpret procedures and regulations.
- Strong communication skills (verbal, written, and presentation).
- Ability to manage multiple tasks, set priorities, and meet deadlines.
- Ability to work with minimal supervision.
Skills:
- Laboratory techniques.
- Data analysis.
- Technical documentation.
- Regulatory understanding.
- Time management.
- Attention to detail.
Should Have:
- ASQ certifications (CQE, CQA, CQM, etc.) preferred.
- Strong judgment and reasoning ability.
- Ability to interpret and apply regulations (GMP, ISO 13485, EN standards).
- Ability to explain regulatory interpretations to teams and auditors.
Qualification and Education:
- Technical or Associate degree in a scientific field preferred.
- Training or coursework in quality, laboratory, or regulatory environments is beneficial.
