SHIFTNo Shift ($0) (United States of America)
A BRIEF OVERVIEW
The 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).
EDUCATION QUALIFICATIONS
Associates of Science (A.S) (Required)
Bachelor of Science (B.S) (Required)
EXPERIENCE QUALIFICATIONS
No previous work experience required (Required)
2+ Years of Experience in a Manufacturing Environment (Preferred)
Experience in Medical Device Manufacturing (Preferred)
LICENSES AND CERTIFICATIONS
Any Quality Certification (Preferred)
KNOWLEDGE & SKILLS THAT ENABLE SUCCESS
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
PHYSICAL DEMANDS
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 -
WHAT WE OFFER
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
ADDITIONAL REQUIREMENTS
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
EOE, including disability/vets.
