Quality Engineer
Apply NowCompany: Cynet Systems
Location: San Diego, CA 92154
Description:
Job Description:
Pay Range: $54hr - $60hr
Responsibilities:
Pay Range: $54hr - $60hr
Responsibilities:
- Review, sign off on batch record, scan, and store daily batch records and line clearance records for reagent R&R process.
- Manage and retain records for the R&R verifier qualification program.
- Scan, upload, and physically store QMS records (i.e., EMS reports, training records, validation reports, etc.) per document retention policy.
- ddress issues pertaining to material master data and material manufacturing batch discrepancies
- Manage ABI-OEM material program including quarantining incoming material batches, pulling QC & QA samples, shipping samples to appropriate testing & inspection sites, managing batch paperwork, and releasing product.
- Initiate or create material nonconformance report (NCMR) or quality notification (QN) in event of quality issue, be able to support root cause investigation, and support the execution of corrective actions.
- Manage nonconforming inventory (physically and systemically)
- Manage nonconforming inventory:
- Physically quarantine and tag nonconforming materials
- Maintain MRB cage material log
- Systemically move and block materials in SAP
- Validation: Execute on equipment IQ/OQ under the guidance and supervision of the Staff Quality Engineer or designee.
- Training - Maintain training compliance for self. Support training of junior teams either within QA or from cross functions.
- Quality Metrics - Gather quality data, create a quality trending chart, and analyze of trending for quality system review and management review.
- Keeps manager informed of important changes/issues affecting product release or quality issues arising from the Manufacturing floor.
- Follow Environmental, Health, and Safety (EH&S) policies and procedures.
- Takes responsibility for safety in immediate work area.
- Participates in EH&S programs. Notifies supervisors of all observed hazardous conditions or unsafe work practices.
- May provide recommendations on maintaining the safety of the work environment.
- Supports external customers as well as the following internal customers, such as; Operations, R&D, Production Planning, Quality Engineers, and Logistics
- Performs other related duties and assignments as needed.
- Requires a minimum of a Bachelor's Degree in science, engineering, or other relevant discipline.
- minimum of 7 years of relevant experience or a combination of higher education and relevant experience.
- Basic knowledge of ISO 9001, ISO 13485, and other applicable regulatory bodies.
- Limited/Basic application of Quality Systems principles and applicable Regulatory and/or Business requirements
- Self-driven and detail-oriented.
- ble to work independently and with minimal supervision.
- Demonstrated ability to perform detail-oriented work with a high degree of accuracy.
- Effective time management skills.
- bility to handle multiple tasks and meet deadlines.
- Effective organization, planning, and prioritization skills.
- Effective analytical and problem-solving skills.
- Effective written and oral communication skills.
- Effective interpersonal skills.
- Demonstrated ability to follow established policies and procedures.