Quality Engineer
Noblesville, IN 
Share
Posted 3 months ago
Job Description

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.

 

Job Summary
Company
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Education
Bachelor's Degree
Required Experience
5 to 7 years
Email this Job to Yourself or a Friend
Indicates required fields