- Manufacturing Experience
- Root Cause Analysis
- Laboratory Experience
- FDA Regulations
Dedicated to helping foster healthy environments through the design and manufacturing of FDA-regulated wipes, Iatric is recruiting for a Quality Engineer to join the team. The Quality Engineer will develop and execute validation protocols (IQ / OQ / PQ) as required for equipment, sanitation/cleaning, facilities, software, and processes. Will also work with customer’s regarding customer specific equipment and process validations. In addition, this role will have the opportunity to:
Facilitate and maintain validation project documentation, including site’s Validation Master Plan.
Serve as the Database administrator for Infinity QS (Statistical Process Control) software.
Provide statistical analysis support for manufacturing, new product development (NPD), trials, and validation activities.
Develop SOP’s relating to validation and risk management.
Monitor and prepare Key Performance Indicators (KPI’s) for major customers.
Conduct quality/engineering studies to support manufacturing operations.
Facilitate Corrective Action / Preventative Action (CAPA) activities to identify and resolve root cause issues through sound investigation and effective problem-solving techniques to solve problems within the manufacturing plant.
Facilitate and train associates on quality topics required for their position (SPC / CAPA).
Coordinate continuous improvement initiatives alongside internal and external (customer or supplier) representatives.
Bachelor’s degree in Engineering, science or related field is required.
Three+ years of engineering experience, preferably in a manufacturing environment is required.
Experience in an FDA-regulated environment preferred.
Strong self starter and possess the ability to work well individually or in a team setting.
Demonstrated ability to perform technical Non-Conformance investigations and Root Cause Analysis
Ability to work independently as well as collaboratively in a team setting with peers and colleagues in a cross functional setting.
Able to prioritize and handle multiple tasks and ability to meet deadlines in a fast-paced work environment.
Ability to have a flexible work schedule to support department activities and coordinate with production and validation execution schedules.
Has a technical background in nutritional products, laboratory diagnostics, medical devices, pharmaceutical, or similar industry.
3 year(s): •Engineering experience, preferably in a manufacturing environment is required.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)