Ambu
  • - Quality - 53
  • Noblesville, IN, USA
  • Salary
  • Full Time

Position Summary:

Work with a cross functional team in supporting the quality system process including supporting NCRs related to Internal and supplier issues. Audit quality systems for deficiency identification and correction.

Essential Functions:

•     Support engineering on verification/validation studies

•     Champion the creation and closure of NCRs

•     Engage in external audits and FDA Inspection

•     Lead corrective action investigations by applying the elements of corrective and preventive actions, including root cause analysis, problem solving and risk analysis, in resolving quality problems.

•     Analyze non-conformance reports for recurring defects and prepare, coordinate and document corrective action activities as they are related to internal manufacturing processes; customer complaints and internal audits

•     Identify opportunities for improvement through data trending and analysis.

•     Engage in risk assessment process; identification, control and management utilizing risk assessment tools such FMEA

•     Lead, mentor, and coach operation on quality topics related Manufacturing, test, and processes

•     Communicate immediately quality issues that bear high risk to the business and customer.

•     Conduct Quality System and process audits

•     Identifies and implement changes to procedures/systems to maximize efficiency and insure compliance to regulatory and customer requirements.

•     Apply quality concepts and tools including basic statistics to create and/or, interpret information and data as related to inspection, testing and validation.

•     Develop and implement in-process tests and statistical sampling plans for industrialized products from product validations.

•     Authorized signature of Certificate of Compliance for product release: validation approval; Corrective Action Reports.

•     Assist in regulatory filings, updates and assessments.

•     Verifying the complete, accurate and proper performance of all functions, including documentation and training to ensure compliance with quality manual and all production and corporate standards.

•     Initiate further actions regarding the disposition of any component, process or method that does not meet production or corporate standards of quality, efficacy, or safety.

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

•     Monitor compliance with all safety regulations.

•     Review technical publications, articles, and abstracts to stay abreast of technical developments in industry

•     Perform written documentation in compliance with document control procedures.

•     Utilizing standard computer equipment/keyboard, perform computer entry functions.

•     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 leadership in a manner, which does not distract from a positive working atmosphere and relays the commitment of King Systems Corporation to the individual.

•     Maintain high standards of personal appearance and conduct in order to serve as a positive role model for employees.

•     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.

•     Provide accurate, legible, and complete processing documentation.

•     Ensure that all work is performed in compliance with quality manual.

•     While performing the duties of this job the employee is regularly required to sit; use hands to finger, handle, or feel and talk or hear.

•     The employee is occasionally required to stand; walk and reach with hands and arms.

•     The employee must regularly lift or move up to 10 pounds.

•     Specific vision abilities required by this job include close vision, distance vision, color vision, depth perception and ability to adjust focus.

Qualifications / Education:

•     Bachelor's degree in engineering related field of study or 5-7 years' equivalent experience.

•     Four to six years in engineering experience with decision-making capacity.

•     Thorough knowledge of manufacturing procedures.

•     Background in statistical analysis and product/process testing.

•     Ability to handle multiple priorities.

•     Computer software experience to include word processing, database, and spreadsheet packages. Thorough knowledge of the Medical Device Manufacturing industry.

•     Excellent 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.

•     Outstanding leadership skills.

 

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