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1.Conducts a thorough visual inspection of parts returned from the field to ensure that parts meet the acceptance criteria as defined in the current material specification/procedure. 2. Responsible for neat and proper storage of incoming, inspected, & rejected materials. 3. Conducts a thorough visual inspection and documentation review of repaired devices according to specified checklist/procedure ensuring that all required repair were completed and tests results passed and documented accurately. 4.Completes accurate documentation of all inspection/testing data, DHR (Device History Record) and maintains an easily retrievable filing system. 5.Must be comfortable in operating a computer and keying inspections into the data management system. 6.Assist in root cause analysis activities as required. 7.Monitors product and/or process trends at discretion of QA Management. 8.Manages daily priorities and projects to ensure timely completion. 9.Writes Nonconforming Material Report/QN. Communicates issues verbally and in writing to responsible engineers 10.Writes or updates the department's work instructions/procedures as needed. 11. This includes the Standard Operating Procedures (SOP), Departmental Procedures, and Work Instructions. 12. Interacts effectively with peers and internal and external customers - Engineers, Purchasing, Supplier, Planners, Manufacturing Associates, etc. 13.Works in a team environment, supports engineering, reporting dimensional, statistical, capability measurement system data, data collection, etc. 14.Participates and contributes to continuous improvement activities. 15.Monitors changes to applicable procedures and updates training records Keeps abreast of the basic requirements for compliance in own area of work and complies with those requirements. 16.Participates as required in training on regulatory issues affecting own area of work. Brings regulatory compliance questions/issues to the attention of management. 17.Follows Environmental, Health and Safety (EH&S) policies and procedures. 18.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. 19.Performs other related duties as assigned by QA Management.
• A minimum of a High School Diploma/GED. • Previous experience working in an ISO/FDA regulated environment • 6 months to 1 yr experience in inspection activities that includes; visual & documentation review. • Effective interpersonal and problem-solving, skills. • Detail Oriented • Demonstrated ability to follow established policies and procedures. • Effective writing, verbal communication skills. • Good organizational and prioritization skills • Ability to read and interpret engineering drawings • Knowledge of Excel, Word, Access Database, and/or other industry software. • Ability to handle multiple assignments • Auditing experience – process, systems, documentation, etc. 1 year experience working in a regulated manufacturing environment such as a GMP, SMP, and/or ISO environment.
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About LanceSoft Inc
Lancesoft is one of fastest growing and largest clinical staffing firm in the U.S. and an employer-of-choice for over 1000+ consultants - this may be your opportunity to join us!
We recruit top-notch talent for Healthcare, Pharmaceutical, Technology, Telecom, Retail and Distribution, Energy & Utilities, Banking/ Finance, Manufacturing, Automobile, Media, Transportation, and Government clients coast-to-coast across the US, Canada and India. We are one of the fastest-growing companies in the industry and
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