Location
Farmington Hills, MI | United States
Job description
JOB SUMMARY
The Quality Engineer II supports the ongoing quality of the companys legacy products and works with project management and manufacturing engineers to support new production introduction and ongoing validation.
JOB FUNCTIONS
Essential Functions
- Completes all required training.
- Uses quality tools to implement improvements including: process flowcharting Pareto analysis correlation and regression analysis significance tests design of experiments statistical process control gauge repeatability and reproducibility and trend analysis techniques.
- Acts as a customer liaison and processes customer quality complaints as applicable.
- Collects Analyzes and Presents data using statistical methodology
- Assists suppliers with the interpretation of quality requirements as applicable.
- Assists the development of essential QMS deliverables/Advanced Product Quality Planning (APQP) including but not limited to: complaint analysis risk analysis failure mode and effects analysis CAPA and process/equipment/software verification / validation
- Plans and/or conducts process and equipment validations and special validations including installation qualification (IQ) Operational Qualification (OQ) and Performance Qualification (PQ).
- Interfaces with appropriate customer contacts to clarify customer requirements
- Determines machine and/or process capability through planning and/or executing Process Capability studies
- Develops inspection criteria that connect customer requirements and manufacturing processes that include identification of key characteristics associated sampling plans and required gauging.
- Conceives and/or Leads productivity improvements and/or Continuous improvement projects
- Monitors engineering production processes and products for adherence to internal and external requirements and practices.
- Participates in pre and postproduction launch reviews providing quality engineering support
- Performs quality reviews and internal audits; evaluates data and writes associated reports
- Recommends modifications to existing quality or production standards where applicable to achieve optimum quality within limits of equipment capability.
- Reviews and approves product/process and document change requests.
- Reviews drawings to evaluate quality requirements including: correct application of geometric dimensioning and tolerance proper use of process and material specifications and key characteristics for inspection plans and gauging techniques.
- Supports measuring and analyzing key metrics to monitor performance.
- Works with crossfunctional teams to solve production and quality problems.
- Reinforces safety expectations. Ensures safety operating practices are demonstrated. Reports issues/concerns to Supervisor.
- Support quality and compliance by adhering to all procedures work instructions and forms per the Quality Management Systems (QMS).
Requirements
QUALIFICATIONS
Education
- Bachelor of Science (B.S) Engineering (Required)
Work Experience
- 3 Years of Experience (Required)
- 3 Years of Experience in a Manufacturing Environment (Preferred)
- Experience in Medical Device Manufacturing (Preferred)
Licenses and Certifications
- Any Quality Certification (Preferred)
PHYSICAL DEMANDS/WORKING CONDITIONS
Physical Demands
A thorough completion of this section is needed for compliance with legal standards such as the Americans with Disabilities Act. The physical requirements described here are representative of those that must be met by an employee to perform the essential functions of this job successfully.
- Must be able to remain in a stationary position frequently.
- Must be able to move about the inside of the building occasionally.
- Must be able to move equipment around the building occasionally.
- Must be able to position oneself and move under/around/over equipment frequently.
- Must be able to communicate and exchange information with others frequently.
- Must be able to distinguish and detect information such as writing and defects frequently.
Working Environment
While performing the duties of this job the associate is required to work within the selected working environments.
QMS
Job tags
Salary
