Quality Assurance

Roles & Responsibilities 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. Skills & Certifications 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