Orchid Orthopedic Solutions Quality Engineer, Sustaining Product Quality, Orchid Chelsea in Chelsea, Michigan
SUMMARY OF POSITIONThe Quality Engineer, Sustaining Product Quality supports the ongoing quality of Orchid's legacy products and overall efficacy of the Quality Management System (QMS). This position reports directly to the site quality leader and works with team members in quality, manufacturing, and engineering.
No Shift - $0 (United States of America)
WHAT YOU WILL DO
- Uses quality tools to implement improvements including, but not limited to: process flow charting/mapping, Pareto analysis, correlation and regression analysis, significance tests, design of experiments, statistical process control, gauge repeatability and reproducibility, and trend analysis techniques/statistical techniques, trend analysis, DMAIC/Six Sigma, etc.
- Monitors engineering production processes and products for adherence to company and regulatory standards and practices. Participates in and leads in quality improvement initiatives and projects.
- Performs and/or supports quality reviews and internal audits; evaluates data and writes associated reports to validate or indicate deviations from existing standards.
- Conducts Authors and assists in execution of process and equipment validations.
- Acts as a customer liaison and through processing and involvement with/processes customer quality complaints.
- Assists the development of essential QMS deliverables including, but not limited to: complaint analysis, risk analysis, failure mode and effects analysis, CAPA, and process/equipment/software verification/validation.
- Authors, Reviews, and approves quality documents and change requests.
- Work with production to document current process parameters and develop written instructions to eliminate unnecessary process variations.
- Participates in pre- and post-production reviews providing quality engineering support.
- Collects the required data and chart the quality goals established by the management team.
- Supports measuring and analyzing key metrics to monitor performance.
- Leads productivity improvements by providing quality guidance.
- Works with cross-functional teams to solve production and quality problems.
- Lead Serves as a leader for quality and compliance by utilizing One Orchid global processes and applying knowledge in order to complying with all Quality Management Systems (QMS) documentation requirements and establishing/supporting plan(s) to meet/exceed Key Performance Indicators (KPIs) for Quality that support Safety, Compliance, Six Sigma Quality, On-Time Delivery (OTD) and financial objectives.
WHAT WE ARE LOOKING FOR
2+ Years of Engineering or Quality Experience (Required), Experience Working in a Regulated Industry such as Medical, Aerospace, or Automotive
Bachelor: Engineering (Required)
CQE, CRE, CQA, CQM - ASQ, GD&T - Any
KNOWLEDGE & SKILLS THAT ENABLE SUCCESS
Final Inspection (Extensive Experience), Manufacturing Regulatory Environment (Working Experience), Problem Solving (Extensive Experience), Quality Management (Working Experience), Statistical Analysis and Measurement (Extensive Experience)
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 all connected
- Results: We are all driven
- Occasionally moves heavy equipment, boxes, and other materials and tools
- Constantly operates a computer
- Frequently inspects and places parts
- Candidates offered employment must submit to a pre-employment background check and pre-employment drug test
- Candidates must be able to provide proof of eligibility to work in the United States through eVerify
EOE, including disability/vets
Position: Quality Engineer, Sustaining Product Quality, Orchid Chelsea
Company: Orchid Orthopedic Solutions
Job Location(s): Chelsea, MI
Start Date: As soon as possible
Employment Term: Regular
Employment Type: Full Time
Starting Salary Range: Not Provided
Required Education: Bachelor's Degree
Required Experience: Open
Required Security Clearance: None
Related Categories: Engineering - General, Quality Assurance/Safety, Engineering - Electrical