Position Summary

The Quality Engineer will work with the engineering, product development, and production management to identify to monitor, analyze, and report on product quality and associated programs directed to improve quality. This will include performing root cause analysis of defects and scrap, working with manufacturing engineers, product development, and production management to monitor and develop solutions to these problems.

Assist in the review and follow up of material/equipment/process qualifications and design control projects.

This position may be required to conduct internal and external quality audits.

The Quality Engineer has some responsibility for the inspection of incoming raw materials/components and products at various stages of production process, per documented specifications.

This position will also be responsible for the maintenance of the Material Review Board system and related control of nonconforming materials and products. Assist in the maintenance of the Corrective Action System and will assist responsible functions in the identification of root cause and adequate corrective/preventive actions.

 This is a full-time salaried position.

ROLE SPECIFIC COMPETENCIES

  • Successfully follows all written procedures

ESSENTIAL DUTIES and RESPONSIBILITIES (including but not limited to)

  • Perform routine quality oversight of controlled manufacturing processes and verify that production is following documented work instructions.

  • Monitor that material is properly identified, is traceable, and that equipment is calibrated and maintained properly.

  • Support manufacturing equipment inspections.

  • Help to monitor and maintain Quality metrics to support company goals

  • Assist engineering in product design verifications and material/equipment/process qualifications/validations, per documented protocols

  • Perform incoming inspection or 1st article inspection on raw materials/components according to written procedures/drawings

  • Inspect and test in-process and final assemblies according to written procedures

  • Maintain the Material Review Board system and support internal procedures for identification and disposition of discrepant material

  • Perform other QA activities as assigned by Quality Manager

  • Perform other duties as assigned

MINIMUM QUALIFICATIONS:

Education:
This position requires a Bachelor’s degree in chemistry or related field.

Knowledge of:

  • FDA, cGMP, ISO and applicable Quality System Standards

  • Proficient in Microsoft Word, Excel and Access computer programs

Skills and Abilities to:

  • Perform activities to support product development, administration, manufacturing, and release as identified to Senior Management

  • Demonstrate proficiency utilizing metrology/inspection tools

SUPERVISORY RESPONSIBILITIES
This position does not have supervisory duties

WORK ENVIRONMENT and PHYSICAL DEMANDS

Work is usually performed in a warehouse and office environment, utilizing standard warehouse and office equipment and common warehouse office tools.  The noise level in the work environment is usually moderate.  While performing the duties of the job, the employee is regularly required to talk and hear.  The employee is frequently required to move and use hands. The employee is constantly required to stand; walk; reach with hands and arms; lift and/or move up to 50 pounds.

 To fulfill the requirements of the essential duties and responsibilities, an individual must be able to perform each duty satisfactorily.  The requirements and environmental characteristics described above are representative of the knowledge, skills, ability, and physical elements necessary for the position.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.