Location
Mentor, OH | United States
Job description
Summary: The Senior Quality Engineer is responsible for supporting the organization to ensure quality and production goals are met. The Senior 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.
- Manages NonConforming Material Reports system and dispositions all nonconforming product.
- Enhances and drives product risk management activities. Ensures identified activities and mitigations are executed.
- Participates in technical discussions and riskbased decision making.
- Identifies opportunities and recommends improvements to quality system and manufacturing processes; drives continuous improvement.
- Establish effective corrective action plans. Lead in implementation of quality assurance plans process controls and CAPA systems designed to meet or exceed internal and external requirements.
- Recommends test methods and statistical process control procedures for achieving required levels of product reliability.
- Conducts or guides testing and data analysis which demonstrate that new processes meet acceptance criteria including capability studies and Gage R&R studies.
- Acts as main Quality Engineering contact for assigned customers and projects.
- May supervise quality technicians and/or inspectors as needed at the manufacturing facility.
Competencies/Essential Functions: To perform the job successfully an individual should demonstrate the following:
- 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
Education and/or Experience:
- Candidates should have a BS in an engineering science plus 35 years of manufacturing experience or an equivalent combination of education and experience.
- Ability to utilize statistical analysis and problemsolving techniques to determine product acceptance and evaluate process capabilities.
- Ability to read and interpret blueprints as well as have a Knowledge of GD&T and Inspection methods.
- An understanding of quality standards (ISO 13485) & regulatory requirements (21CFR820).
Physical Demands/Work Environment:
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.
Job tags
Salary
