Ambu
  • - Quality - 53
  • Noblesville, IN, USA
  • 12.00
  • Hourly
  • Full Time

Position Summary:

Monitor compliance to in-house standard operating procedures (SOP's) and Current Good Manufacturing Practices (CGMP's), pertaining to the manufacturing, packaging, storage, and distribution of finished product.

Essential Functions:

•    Inspect and test components, labeling, sub-assemblies and finished product for conformance to all written specifications.

•    Ensure complete, accurate, and proper performance of all QA functions, including documentation.

•    Monitor all processing steps to ensure conformance to Manufacturing specifications (work order) and processing methods.

•    Identify any component, process or method which does not meet specification.

•    Take steps to preclude the use of any non-conforming product or component.

•    Communicate to the Quality Assurance Supervisor, any problem, idea or solution which pertains to the QA job function.

•    Perform timed interval inspections on production processes to insure product quality and conformity to specifications.

•    Perform first article inspections for all sub-assembly and finished product processes to insure product quality and accuracy of labeling, lot numbers, and signatures.

•    Perform periodic air tests to insure quality of circuit lines, as required by Acceptable Quality Levels.

•    Perform finished product inspections according to AQL.

•    Assist in review and filing of all completed work orders.

•    Perform inspection of incoming product according to AQL.

•    Perform return product inspection.

•    Verify return product customer claims.

•    Assist in verifying the complete, accurate and proper performance of all Quality Assurance functions, including documentation to ensure compliance with CGMP's, and ISO 9001, MDD, EN46001, production and corporate standards.

•    Assist in initiating further actions regarding the disposition of any component, process or method that does not meet production or corporate standards of quality, efficiency, or safety.

•    Perform and document any investigation regarding the disposition of any non-conforming process or

•    component, and its effects on products manufactured and distributed by King Systems Corporation and relay results to the appropriate personnel.

•    Communicate to the appropriate personnel, any problem, idea, or solution which pertains to the Quality Assurance Department and/or its interaction with other departments.

•    Ensure all processing steps are performed in accordance with manufacturing specifications (work orders) and production procedures.

•    Must maintain quality standards by separating/relocating non-conforming/sample material from conforming material

•    Ensure compliance of production processes with applicable procedures.

•    Ensure compliance with all safety regulations.

•    Ability to lift and carry up to 40 pounds.

•    Utilizing basic mathematical addition/counting principles, ensure accurate product quantities.

•    By visual review, ensure that assembly of parts is performed according to the work order drawing.

•    Interpret written specifications for assembly of product.

•    Visually inspect products for defects.

•    Carry out assignment rotation, with movement from one work station to another.

•    Standing for long periods of time, work on line or at work station.

•    Perform verbal communication with various employees on work station team or in support of work station team.

•    Perform written documentation in compliance with document control procedures.

•    With proper ventilation equipment in place and safety equipment provided, perform assembly with various chemical adhesives/lubricants.

•    Distinguish color to identify product or defective product.

•    Work around mechanically and/or electronically controlled equipment with moderate noise levels.

•    Analyze data output in the pursuit of operational improvement, development and performance enhancement.

Performance Criteria:

•    Respond to problems, ideas, and solutions presented, in conjunction with Corporate needs and policies.

•    Provide advice and recommendations to assist the Quality Assurance Department in making sound decisions to ensure the maximum efficient use of all personnel and equipment based on the needs of the company.

•    Maintain a professional, helpful attitude in dealings with co-workers, supervisors, and their departmental personnel, at all times.

•    Maintain a clean and organized work area at all times.

•    Ensure compliance with all SOP's.

•    Maintain a strong commitment to quality at all times.

•    Remain flexible with regard to job assignments, at all times.

•    Provide accurate, legible, and complete processing documentation.

•    Ensure that product is produced/assembled in accordance with work order.

•    Take all necessary precautions to ensure that the product is protected from contamination.

•    Practice good hygiene

•    Provide equal contribution to team.

•    Ensure that all work is performed in compliance with CGMP's, and ISO9001, MDD, EN46001 requirements.

•    Maintain respect for all equipment used in the performance of your job.

 Qualifications / Education:

 •    High School diploma or general education degree (GED); or one to three months related experience and/or training; or equivalent combination of education and experience.

•    Ability to perform routine math calculations.

•    Ability to read and interpret documents of instruction.

•    Complete understanding of ISO9001, MDD, EN46001 and CGMP requirements.

•    Understanding of manufacturing procedures.

•    Ability to handle multiple priorities.

•    Good verbal and written communication skills.

•    Ability to work independent of direct supervision.

•    Ability to work well with others.

•    Ability to complete routine reports and correspondence.

•    Excellent hand eye coordination

•    Ability to apply common sense understanding to carry out written or oral instructions.

•    Excellent attention to detail.

Ambu
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