Quality Assurance
2 weeks ago
DUTIES AND RESPONSIBILITIES
- Perform documentation verification, visual & dimensional inspection of raw materials, returns from the field, repaired/refurbished finished products according to established acceptance criteria that is defined in material specifications, engineering drawing, OMS, Test Procedures, etc.
- Assess the dimensional accuracy of machined parts using the appropriate inspection methodology & measuring tools.
- Conduct a thorough documentation review, ensuring that all recorded information is complete and meets the requirement of Good Documentation Practices
- Clearly and accurately record the result of inspection on applicable forms or electronically in SAP.
- Communicate issues verbally and in writing to responsible engineers.
- Document discrepancies found during inspection process in accordance with the Quality Notification Reporting procedure.
- Ensure that quality records are complete when saving/uploading to SAP
- Follow the standard operating procedures (SOP).
- Ensures timely completion of daily work assignments.
- Support and contribute to the attainment of the department/business goals.
- Interact effectively with peers.
- Adhere to Client San Jose's Quality System requirements & client Values.
- Participate and contribute to continuous improvement activities.
- Monitor changes to applicable procedures and completes training in a timely manner.
- Keep abreast of the basic requirements for compliance in own area of work and complies with those requirements.
- Participate as required in training on regulatory issues affecting own area of work. Brings regulatory compliance questions/issues to the attention of management.
- Follow BDIS Environmental, Health and Safety (EH&S) policies and procedures.
- Take responsibility for safety in immediate work area. Participates in EH&S programs. Notifies supervisor of all observed hazardous conditions or unsafe work practices. May provide recommendations on maintaining the safety of the work environment.
Experience Required
- 1-2 years' experience working as Quality Assurance Inspector in a GMP, FDA or ISO 9000 environment.
MINIMUM QUALIFICATIONS
KNOWLEDGE AND SKILLS
- Experience in performing the duties/responsibilities described above.
- Experience in First Article Inspection
- Experience in data entry - BMRAM (Blue Mountain Regulatory Asset Management, SAP, etc.
- Highly detail oriented
- Ability to read and interpret engineering drawings
- Have a very good understanding of Good Documentation Practices.
- Good organizational and prioritization skills
- Ability to multi-task
- Must possess good problem-solving skills
- Computer literate with basic knowledge or Microsoft Windows & Office, SAP, Minitab, etc.
- Adaptive, collaborative, agile,
- Proficient verbal & written communication skills
- Team-oriented with commitment to the success of the team and organizational goals to track and complete assignments.
- Experience working under GMP, or ISO 9000 environment
Eligibilities & qualifications
EDUCATION
High School Diploma or equivalent
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