The Quality Engineer is responsible for the inspection of incoming raw materials/components and products at various stages of production process, per documented specifications. Will assist in the determination and completion of First Article inspections, as necessary. This position will also be responsible for the maintenance of the Material Review Board system and related control of nonconforming materials and products. Assist Quality Management in the maintenance of the Corrective Action System and will assist responsible functions in the identification of root cause and adequate corrective/preventive actions. Support the Production department by observing processes and products on the manufacturing floor. The Quality Engineer will work with engineering and production departments to identify root cause and solutions for issues of membrane and element scrap and assist Quality Management by supporting and directing QA Inspection staff to maintain internal and external calibration system. This position will assist Quality Management in the review and follow up of material/equipment/process qualifications, design control actions and the internal environmental control team with monitoring activities and follow up.
This position may be required to conduct internal and external quality audits.
ROLE SPECIFIC COMPETENCIES
- Successfully follows all written procedures
ESSENTIAL DUTIES and RESPONSIBILITIES (including but not limited to)
- 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
- Maintains the Material Review Board system and supports internal procedures for identification and disposition of discrepant material
- Assist engineering in product design verifications and material/equipment/process qualifications/validations, per documented protocols
- Oversees maintenance of MICRODYN-NADIR US Calibration System
- Perform routine quality oversight of controlled manufacturing area for material identification, traceability, equipment calibration and equipment issues that may require attention.
- Supports manufacturing equipment inspections.
- Help to develop and maintain Quality metrics to support company goals
- Oversees routine QA environmental testing and reporting, per documented matrices and instruction, and upon request by Production or Engineering functions.
- Perform other QA activities as assigned by Quality Manager
- Perform other duties as assigned
A Bachelor’s degree in chemistry or related field is required.
Training and Experience:
Minimum three (3) years’ experience in similar role
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
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.