Quality Engineer

Quality Engineer

The Quality Engineer will be responsible for writing procedures associated with mechanical drawings, documents, and maintaining the Preventive Maintenance Program (PMP) etc. for the Engineering Department & Quality. The writer will be responsible for the administration and control of SOPs that are received, created, or issued by the Engineering team. This person will work closely with QA and Production.

Key Responsibilities

• Creates and updates procedures, specs, and drawings in electronic drawing management systems. Familiarity with SharePoint preferred
• Creates PMPs for all process and supporting equipment and is responsible for ensuring the execution of these programs.
• Complete administrative and analytical support with the Production and QA document control services
• Demonstrates adherence to QA document services policies, procedures, standards, and guidelines
• Ensures document transmittals by others are accurate and complete
• Utilizes interpersonal skills in maintaining balance with all parties' requirements and priorities
• Proactively communicates with the production and QA staff and internal teams to manage workload and project requests
• Author SOP's calibration procedures, maintenance procedures, out of tolerance notifications and change controls as applicable for all qualified and non-qualified systems
• Review calibration and maintenance procedures for accuracy and completeness.
• Maintains good documentation practices, storage, and organizational policies
• Performs periodic updates to procedures to improve efficiency
• Performs other related duties as assigned by management

Education and Experience

• Experience in Quality and PMPs are required.
• Associate degree or higher preferred
• 2 years of previous document control experience, or quality assurance environment, or in a like technical environment
• Microsoft Office Applications Experience (i.e. Excel, Word, etc.)
• Strong communication and organization skills, both verbal and written

Knowledge, Skills, and Abilities

• High attention to detail
• Ability to interpret a variety of instructions furnished in written and oral form
• Ability to work on multiple tasks and prioritize work
• Ability to work cross-functionally as a team
• Possess the skills and ability to coordinate, facilitate, and participate in a collaborative approach for the completion of tasks and assignments
• General understanding of engineering documents, FDA requirements, etc.
• Excellent understanding of department operating practices and procedures

Physical/Work Environment/Expectations

• GMP Manufacturing Environment
• The work environment, typical of an office environment, characteristics described here are representative of those encountered while performing the essential functions of this job.

Note: This job description is not totally inclusive, nor it is designed to cover or contain a complete comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.