Quality Engineer
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Job Description
Summary:
The Quality Engineer is responsible for supporting the organization to ensure quality and production goals are met. The Quality Engineer will utilize an engineering approach to improve manufacturing efficiencies and ensure quality standards of all products are met.
Duties/Responsibilities: include the following. Other duties may be assigned.
- Serves as a quality representative to assigned manufacturing areas and/or customers. Responsible for ensuring compliance with company procedures; customer requirements; and industry regulations, including FDA Quality System Regulation and ISO 13485.
- Supports operations and engineering teams to ensure the Material Review Board process is followed.
- Provides ongoing quality engineering support to operations, including risk management, developing appropriate inspection requirements; and complaint/NC/CAPA investigations.
- Submit documentation to customers for new product launches and legacy product documentation requests.
- Leads assigned team in the development of quality related processes & initiatives.
- Monitor complaint trends and data in order to escalate emerging issues appropriately.
- Identify and implement effective process control systems to support the development, qualification, and ongoing manufacturing of products to meet or exceed internal and external requirements
Requirements
- Candidates should have a BS in an engineering science plus 0--3 years of manufacturing experience, or an equivalent combination of education and experience.
- Ability to utilize statistical analysis and problem-solving techniques to determine product acceptance and evaluate process capabilities.
While performing the duties of this job, the employee is required to stand, walk or sit, occasionally for long periods of time; use hands to hold, handle or feel objects; reach with hands and arms; balance; stoop, kneel or crouch; talk or listen. The employee may occasionally lift and/or move up to 50 pounds (seek assistance for greater amounts). Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, depth perception and the ability to adjust focus. The noise level in the work environment is usually moderate. Employees may be exposed to hazardous materials. Employees need to consult SDS in their work area.
Employment Type
Full Time
