Quality Engineer

The primary responsibilities of the Quality Engineer II are to document and execute process validations on various types of manufacturing equipment, as well as providing technical engineering support to the operations group as required. Quality Engineer II will also serve as a trainer for less experienced Engineers and a technical resource for PM's or clients. Other responsibilities include the creation of manufacturing work instructions, training of operations personnel and interfacing with customers on technical issues, and coordinating workload within the Engineering dept.Skills Required-Mechanical Aptitude Ability to train production operators during process qualifications Adept in use of calipers, micrometers and other test equipment Able to guide others in the use of test equipmenttooling Mechanically inclined in the installation, set up and operation of production equipment Ability to establish operating parameters for production equipment Ability to assess a situation with mechanical devices and develop plans to address issues that arise. Writing Skills Technical writing skills for validationsprocedures IQ, OQ, PQs Ability to createedit componentpackaging drawings Report writing Review the work of others providing corrections andor guidance as needed Attention to detail Ability to write Client Specific Validation accurately Ability to write Client Specific Procedures accurately Ability to review and correct proceduresprints for accuracy Ability to make improvements to existing and proposed documents Organizational skills Ability to multitask Assist with department scheduling and priority setting. Take on additional responsibilities during start-up phase to assist Program Management. Find opportunities to improve processes and implement those improvements Math skills Basic additionsubtraction Advanced skills - algebra Ability to record and interpret test data, compile reports Ability to understand statistical tools and use those tools to prove or disprove a theory. Ability to present statistical data verbally and written Software & Computer skills Basic knowledge - Familiar with hardware Mid-level - Familiar with Microsoft Office (Word, Excel, Powerpoint) Advanced - Ability to create spreadsheets and other documents AutoCad Mini-Tab GMPs (Good Manufacturing Practices) Knowledge of GMPs Ability to guide others to maintain GMP compliance Interpersonal skills Ability to interact with all levels of the facility Ability to interact with clients and interpret their needs Escort clients within facility and provide technical expertise as needed Ability to work and interact in a team environment Ability to work assigned tasks unsupervised Comfortable acting as an authority in technical issues Act as department lead in the absence of department management

Created: 2025-02-21