Vacancy expired!
ABOUT US
Our climate controlled 31,000 square foot facility in Chelsea, MI specializes in medical grade plastics machining and injection molding. A career with Orchid provides growth opportunities, a great benefits package including performance bonuses, insurance, 401(k) with company match, paid time off and schedule flexibility. For more information, view our website. SHIFTNo Shift ($0) (United States of America)A BRIEF OVERVIEWThe Quality Engineer I supports the ongoing quality of Orchid's legacy products & processes and works cross-functionally to sustain the business. WHAT YOU WILL DO- Provides and documents training on standard of work instructions, policies, and procedures in a timely manner to ensure team members have the required knowledge and skills prior to performing work independently.
- Uses quality tools to suggest and 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).
- Aids in the determination of 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.
- Interfaces with appropriate customer contacts to clarify customer requirements
- 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 post-production 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 cross-functional teams to solve production and quality problems with minimal assistance.
- 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).
- Associates of Science (A.S) (Preferred)
- Bachelor of Science (B.S) (Preferred)
- 2+ Years of Experience in a Manufacturing Environment (Preferred)
- Experience in Medical Device Manufacturing (Preferred)
- Any Quality Certification (Preferred)
- Operational Functions - Working Experience
- Quality Management - Working Experience
- Process Management - Working Experience
- Communication - Basic Knowledge
- Accuracy and Attention to Detail - Working Experience
- Manufacturing Safety - Working Experience
- Lean Manufacturing - Working Experience
- Statistical Analysis and Measurement - Basic Knowledge
- Production Part Approval Process (PPAP) - Basic Knowledge
- Production Runs - Working Experience
- Final Inspection - Basic Knowledge
- Computer Knowledge - Working Experience
- Problem Solving - Working Experience
- Must be able to remain in a stationary position -
- Must be able to move about the inside of the building -
- Must be able to move equipment around the building -
- Must be able to ascend/descend stairs or ladders -
- Must be able to position oneself and move under/around/over equipment -
- Must be able to handle/adjust/inspect/position various items and equipment -
- Must be able to communicate and exchange information with others -
- Must be able to perform tasks that require repetitive handling/adjusting/inspecting/positioning of items and equipment -
- Must be able to distinguish and detect information such as writing and defects -
- Must be able to move equipment -
- Noise - Frequently
- Opportunity to work in a growing company
- Ability to help people live a longer, more active life
- Comprehensive benefit package
- Ability to work in an organization that values:
- Integrity First: We do the right thing
- Teamwork: We are one Orchid
- Results: Our results matter
- Candidates offered employment may be required to submit to a pre-employment background check and pre-employment drug-screening based on position requirements
- Candidates must be able to provide proof of eligibility to work in the United States through eVerify
Vacancy expired!