Maxonic Inc.
Maxonic maintains a close and long-term relationship with our direct client. In support of their needs, we are looking for a
Senior Validation Quality Engineer . Job Title: Senior Validation Quality Engineer Work Schedule: On-site Rate: $52/hr, Based on experience. Job Description
This position will provide validation, engineering and technical support for all facilities supporting Manufacturing and Distribution. It will coordinate and execute product and process validations as appropriate to the Quality Department. It will evaluate the operation of Manufacturing and Quality activities in relation to compliance to Quality Standards and Regulations and recommend where corrections or improvements are indicated. The position will provide direct support to Quality Management/Quality personnel regarding operation of the department and Quality System. It will provide support to other departmental activities as directed. Responsibilities
Processes: Oversee the operation of the Quality System process related to product, process, and/or test method Validation and Re-Validation. Oversee the Installation, Operational and Performance Qualification activities for equipment, product, or systems installed including those requiring computerized operation/interfacing. Support NCR and CAPA: Capture data associated with product deviations, product non-conformances, CAPAs, scrap and rework, and analyzing the data for the purpose of Quality Improvement and reporting. Quality Improvement – Data Analysis: Provide leadership and direction and promote Quality Improvement Processes. Coordinate, and analyze databases associated with oversight of the Quality System and its reporting process. Quality initiatives: Provide quality engineering support for supplier changes and resolution of issues at suppliers. Identifies new quality improvement initiatives / projects in accordance with cGMP expectations to improve compliance, quality levels (reducing defects), and improve operational efficiencies. Inspections: Support with federal, state, and local regulatory officials during regulatory inspections. Support in internal and vendor quality system audits as applicable. Adherence to regulations: Assist with adherence to all Federal, State and Local Regulations controlling the manufacture of medical devices. Requirements
Bachelor's Degree Physical Science or Engineering, or equivalent experience. 3-5 years Minimum in Medical Device or Pharmaceutical Industry or similar experience. 3-5 years Minimum in a Quality Role. 3-5 years Minimum in a Validation Engineering Role. Preferred Qualifications
Minimum 3 years working with electromechanical devices. ASQ Certification as a Quality Engineer. Technical & Functional Skills
Knowledge of quality requirements for medical device / pharmaceutical organization. Strong technical writing skills. Strong technical and general problem-solving skills required; experience with NCR/CAPA processes. Computer skills in Microsoft Word, Excel, PowerPoint, Visio; Adobe; and Quality System Management Software. Experience with Statistical Analysis of Data. Experience with statistical sampling requirements for Process Validation. Familiar with ISO 13485 Quality System Standards, FDA Quality System Regulations, GMPs, and/or other international medical device regulations. Highly effective communication skills. Ability to work with company staff and communicate effectively throughout the organization. Manage multiple priorities and work with interruptions. Ability to work with minimal supervision and to make effective decisions for issues of a diverse and complex scope when required. Maxonic is an equal opportunities employer and welcomes applications from diverse candidates.
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Senior Validation Quality Engineer . Job Title: Senior Validation Quality Engineer Work Schedule: On-site Rate: $52/hr, Based on experience. Job Description
This position will provide validation, engineering and technical support for all facilities supporting Manufacturing and Distribution. It will coordinate and execute product and process validations as appropriate to the Quality Department. It will evaluate the operation of Manufacturing and Quality activities in relation to compliance to Quality Standards and Regulations and recommend where corrections or improvements are indicated. The position will provide direct support to Quality Management/Quality personnel regarding operation of the department and Quality System. It will provide support to other departmental activities as directed. Responsibilities
Processes: Oversee the operation of the Quality System process related to product, process, and/or test method Validation and Re-Validation. Oversee the Installation, Operational and Performance Qualification activities for equipment, product, or systems installed including those requiring computerized operation/interfacing. Support NCR and CAPA: Capture data associated with product deviations, product non-conformances, CAPAs, scrap and rework, and analyzing the data for the purpose of Quality Improvement and reporting. Quality Improvement – Data Analysis: Provide leadership and direction and promote Quality Improvement Processes. Coordinate, and analyze databases associated with oversight of the Quality System and its reporting process. Quality initiatives: Provide quality engineering support for supplier changes and resolution of issues at suppliers. Identifies new quality improvement initiatives / projects in accordance with cGMP expectations to improve compliance, quality levels (reducing defects), and improve operational efficiencies. Inspections: Support with federal, state, and local regulatory officials during regulatory inspections. Support in internal and vendor quality system audits as applicable. Adherence to regulations: Assist with adherence to all Federal, State and Local Regulations controlling the manufacture of medical devices. Requirements
Bachelor's Degree Physical Science or Engineering, or equivalent experience. 3-5 years Minimum in Medical Device or Pharmaceutical Industry or similar experience. 3-5 years Minimum in a Quality Role. 3-5 years Minimum in a Validation Engineering Role. Preferred Qualifications
Minimum 3 years working with electromechanical devices. ASQ Certification as a Quality Engineer. Technical & Functional Skills
Knowledge of quality requirements for medical device / pharmaceutical organization. Strong technical writing skills. Strong technical and general problem-solving skills required; experience with NCR/CAPA processes. Computer skills in Microsoft Word, Excel, PowerPoint, Visio; Adobe; and Quality System Management Software. Experience with Statistical Analysis of Data. Experience with statistical sampling requirements for Process Validation. Familiar with ISO 13485 Quality System Standards, FDA Quality System Regulations, GMPs, and/or other international medical device regulations. Highly effective communication skills. Ability to work with company staff and communicate effectively throughout the organization. Manage multiple priorities and work with interruptions. Ability to work with minimal supervision and to make effective decisions for issues of a diverse and complex scope when required. Maxonic is an equal opportunities employer and welcomes applications from diverse candidates.
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