Mechanical Inspector II

Position:
Mechanical Inspector II

Location:

San Jose, CA

Duration: 6 Months Contract

Start Time: 07:00 AM

End Time: 03:30 PM

Total Hours/week: 40.00 (Mon-Fri)

• A minimum of a High School Diploma/GED; college degree preferred
• 3+ years visual and mechanical inspection experience
• 3+ years experience working in a regulated manufacturing environment such as a GMP, SMP, and/or ISO environment
• Previous experience working in a medical device environment
• Knowledge of Client products is highly desirable
• Effective interpersonal skills
• Demonstrated ability to follow established policies and procedures
• Effective writing and communication skills
• Good administrative skills and knowledge of established rules of metrology, including basic working knowledge of geometric dimensioning and tolerancing – ASME Y 14.5-1994 preferred
• Good organizational and prioritization skills
• Knowledgeable in the use of inspection measuring tools including a CMM/CNC
• Ability to read and interpret complex engineering drawings
• Knowledge of Excel, Word, Access Database, etc.

• Inspects the acceptability of purchased materials by thorough examination (visual/mechanical) according to material specifications and using the appropriate inspection tools and methodology (GD&T Principles)
• Conducts a thorough documentation review, ensuring that all information recorded on quality records is complete and meets the requirements of Good Documentation Practices
• Clearly and accurately records the result of inspection on appropriate inspection forms
• Performs both First Article Inspection and Lot to Lot Inspections; inspection results may be recorded electronically or manually
• Ensures that only calibrated inspection tools are used for inspection and handles tools appropriately to prevent damage
• Reports damaged or lost tools to the department supervisor or manager
• Writes Nonconforming Material Report/QN
• Communicates issues verbally and in writing to responsible engineers; prioritizes work assignments to ensure timely completion; communicates status of workload to the department lead
• Interacts effectively with peers and internal and external customers – Engineers, Purchasing, Supplier, Planners, Manufacturing Associates, etc.
• Should be comfortable operating a computer and keying inspections into the data management system; assists in root cause analysis activities as required
• Performs other tasks in the department such as material handling, organizing the inspection queue area, providing technical support to peers as needed, performing source inspection at the supplier’s site, etc.; adheres to BDB San Jose’s Quality System requirements
• Includes the Standard Operating Procedures (SOP), Departmental Procedures, and Work Instructions
• Works in a team environment, supports engineering, reporting dimensional, statistical, capability measurement system data, data collection, etc.
• Participates and contributes to continuous improvement activities; monitors changes to applicable procedures and updates training records within 14 days after the document's affectivity date
• Keeps abreast of the basic requirements for compliance in own area of work and complies with those requirements
• Participates as required in training on regulatory issues affecting own area of work; brings regulatory compliance questions/issues to the attention of management; follows BDIS Environmental, Health and Safety (EH&S) policies and procedures; takes 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
• Performs other related duties as assigned by QA Management