ABOUT US
Orchid Orthopedic Solutions provides solutions for orthopedic implant procedures enabling a longer, active life. Working in an industry that has the ability to impact lives in such a profound way has proved to be a strong motivator for Orchid. The Lansing facility specializes in the forging and machining of hip and knee implants across our 3 campus. A career with Orchid provides growth opportunities, a great benefits package including performance bonuses, insurance, 401(k) with company match and paid time off. For more information, please visit www.orchid-ortho.com
SHIFTNo Shift ($0) (United States of America)
A BRIEF OVERVIEW
The Quality Engineer, Sustaining Product Quality supports the ongoing quality of Orchid's products. Responsible for providing advanced quality planning and ongoing engineering support. Effectively disseminate customer requirements and generate controls to meet those requirements. Works with engineers, supervisors, managers, production personnel, suppliers and customers to help resolve quality issues, achieve team objectives, and promote quality principles.
WHAT YOU WILL DO
Perform visual and/or cosmetic inspection of product following applicable procedure(s) using appropriate light sources. Monitor equipment to ensure proper operation and escalate any equipment-related issues.
Back up the Quality Documentation Coordinator on Regulatory Release activities per FDA 21 CFR 820.80 (d) when required.
Act as the designated member of the Complaint Handling Unit.
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 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.
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
Bachelor (Required)
Bachelor of Science (B.S) (Preferred)
EXPERIENCE QUALIFICATIONS
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)
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 - Working Experience
Production Part Approval Process (PPAP) - Working Experience
Production Runs - Extensive Experience
Final Inspection - Working Experience
Computer Knowledge - Working Experience
Problem Solving - Working Experience
PHYSICAL DEMANDS
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 - Occasionally
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 CONDITIONS
Noise - Occasionally
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... For full info follow application link.
EOE, including disability/vets.
