Senior Validation Quality Engineer

Title: Senior Validation Quality Engineer

Location - Sturtevant, WI

Duration - 12+ months

Hours - Monday through Friday, 7:30 a.m. to 4:00 p.m.

Pay Rate - $40-50/hr
A Brief Overview


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.


What You Will Do
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. Coordinate other activities associated with installation and proper configuration of new equipment as directed. Provide assistance to the Manufacturers and R&D departments in the development and validation of new products and Manufacturing/Quality Control processes. Review and approve internal operating procedures and specifications.
Support Client 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. Works with manufacturing and other functional groups on manufacturing regulatory compliance issue. Support training program by delivering assigned training tasks.
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.
Other duties as assigned: Provides support to Quality Management personnel and perform other duties as assigned.
Minimum Requirements For Validation Quality Engineer


Bachelor's Degree Physical Science or Engineering, or equivalent experience.
2+ years Minimum in Medical Device or Pharmaceutical Industry or similar experience.
2+ years Minimum in a Quality Role.
2+ years Minimum in a Validation Engineering Role.
Minimum Requirements For Senior Validation Quality Engineer


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 for Validation Quality Engineer


Minimum 2 years working with electromechanical devices.
ASQ Certification as a Quality Engineer or equivalent.
Preferred Qualifications for Senior Validation Quality Engineer


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 Client/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.