- - Quality - 53
- Noblesville, IN, USA
- Full Time
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.
• 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.
• 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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