Mechanical Inspector II

Qualifications

• 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

Responsibilities

• Inspects the acceptability of purchased materials by thorough examination(visual/mechanical) according to material specifications (engineering drawings) and using the appropriate inspection tools and inspection methodology (GD&T Principles).
• Cleans thoroughly documentation review, ensuring that all information recorded on quality records are complete and meets the requirement of Good Documentation Practices.
• Clearly and accurately records the result of inspection on appropriate inspection forms.
• There are two types of inspections - First Article Inspection and Lot to Lot Inspections. Inspection results may be recorded electronically or manually.
• Ensures that only calibrated inspection tool is 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.
• Must be comfortable in operating a computer and keying inspections into the data management system. Assist in root cause analysis activities as required.
• Performs other task in the department, such as; material handling, organizing the inspection queue area, providing technical support to peers as needed, perform source inspection at the supplier’s site, etc. Adheres to BDB San Jose's Quality System requirements.
• This 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.