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.
SHIFT
No 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
EXPERIENCE QUALIFICATIONS
LICENSES AND CERTIFICATIONS
KNOWLEDGE & SKILLS THAT ENABLE SUCCESS
PHYSICAL DEMANDS
WORKING CONDITIONS
WHAT WE OFFER
ADDITIONAL REQUIREMENTS
EOE, including disability/vets
We have the broadest portfolio in the industry, ranging from design and development through finished goods manufacturing and packaging, and we improve our customers’ supply chains through our supply chain solutions.
Orchid specializes in implants, instruments and innovative technologies for the following markets:
Joint reconstruction
Spine
Trauma
Sports Medicine
Extremities
Dental
We are driven to success through our customer-focused team, living out our core purpose and values and striving for continuous improvement.
20 to 49 employees