Job Description:

Work Location: Indianapolis, Indiana
Shift: No
Department: LS-SC-POEQD Indianapolis QA Operations
Recruiter: Leah S Westley



This information is for internals only. Please do not share outside of the organization.




Your Role



The Quality Engineer will provide Quality Assurance support and oversight to the Validation, Maintenance and Engineering teams, reviewing and approving protocols/reports as well as ensuring procedures meet Quality and industry requirements. The Quality Engineer works with the Validation, Maintenance, Engineering and Operations teams to ensure the Indianapolis site stays in a compliant validated state.


Duties/Responsibilities:


Reviewing and approving validation equipment qualification processes and parameters against quality and industry standards. Establish optimized validation qualification and validation planning and requirements. Reviews design plans, process procedures, test procedures, and raw data to understand the scope, requirements, and function of products. Provides oversight and QA approval of Critical System Work Orders and Equipment Change Controls. Ensures products meet the organizations and customers quality and product integrity requirements. Supports product engineering or operations teams by providing analysis and expertise throughout the manufacturing process. Identifies root causes of problems in the production process; recommends and/or implements corrective measures. Analyzes data to identify trends in product quality or defects with the goal of mitigating and preventing recurrence and future defects. Developing test procedures that produce analyzable validation data. Analyzing test data to determine the causes of defects, failure, or flaws and facilitating corrective measures. Performing risk assessments and ensuring compliance with industry standards. Presenting validation test results and recommending improvements. Performs other duties as assigned.


Physical Requirements: Prolonged periods of sitting at a desk and working on a computer. Must be able to lift up to 15 pounds at times.



Who You Are:




Minimum Qualifications:

• Bachelors degree in Engineering or related discipline required. Seven years of related experience required.

Preferred Qualifications:

• Excellent verbal and written communication skills.


• Excellent organizational skills and attention to detail.


• Extensive knowledge of or the ability to quickly learn the organizations production processes.


• Excellent interpersonal skills with ability to serve as a liaison with developers, project managers, and customer support. Strong analytical and problem-solving skills.


• Proficient with Microsoft Office Suite or related software.

The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination. Apply Now