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 equipment/tooling

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 validations/procedures

IQ, OQ, PQs

Ability to create/edit component/packaging drawings

Report writing

Review the work of others providing corrections and/or 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 procedures/prints 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 addition/subtraction

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

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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