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.