Quality Assurance Inspector

Position : Quality Assurance Inspector

Location : San Jose, CA

Duration : 3 Months

Total Hours/week : 40.00

1st Shift

Client: Medical Device Company

Job Category: Quality

Level of Experience: Entry-Level

Employment Type: Contract on W2 (Need US Citizens or GC Holders Only)

Job Description:

• This position will function within the Quality Assurance group.
• The Quality Assurance Inspector is expected to conduct inspection of components, assemblies, finished products, spare parts, repaired parts, repaired/refurbished products, etc., visually, or dimensionally using the applicable test & measuring equipment.
• It is the QA Inspector’s job to perform a thorough verification of documentation (quality records) for accuracy & completeness & records the result of inspection in writing or electronically in SAP database. Discrepancies found are communicated verbally & in writing per the Quality Notification Reporting procedure and assists engineering as needed in the root cause investigation.
• The QA Inspector Is expected to use training, experience, basic knowledge of quality control concepts, practices, and procedures.
• Works under general supervision.
• Quality Assurance strives to live client values as part of an action-oriented team focusing on customer requirements and process effectiveness through continuous learning, influencing of others, and dedication to achieving the highest quality results.
• The QA inspector performs all activities with extreme care.
• The daily tasks performed by this position are critical to the assurance of quality produced product.
• Works effectively in a team environment and emphasized healthy customer relations.
• Responsible for ensuring that procedures & processes are followed.

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 BDB 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.

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

Education And Experience

• High School Diploma or equivalent.
• 1-2 years’ experience working as Quality Assurance Inspector in a GMP, FDA or ISO 9000 environment.