Orchid Orthopedic Solutions is a worldwide leader in design and manufacturing for the orthopedic and medical device markets, including joint reconstruction, spine, trauma, sports medicine, extremities and dental. The company is able to do this by compressing time to market, providing new technologies and being the best total supply-chain value. Orchid provides expertise in design and development, quality and regulatory support, implant manufacture, advanced machining, plastics technology, instrument manufacturing, implant coatings, surface treatments, and packaging services. With 14 world-class facilities located around the globe, Orchid continues to provide others an opportunity to live a better life through the products, services and the way the company conducts business. Orchid employs approximately 2,000 people in six countries – US, UK, Switzerland, Ireland, China and India.
Additional information on the company can be found at www.orchid-ortho.com.
SUMMARY OF POSITION
The Quality Engineer, Sustaining Product Quality supports the ongoing quality of Orchid’s legacy products.
This position reports directly to the site quality leader.
KEY JOB RESPONSIBILITIES
- 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.
- Designated member of the complaint handling unit
- Supports continuous improvement as a change agent for internal rework and scrap reduction and process optimization.
- Performs quality reviews and internal audits; evaluates data and writes reports to validate or indicate deviations from existing standards.
- Conducts process and equipment validations.
- Liaise with suppliers and customers to address concerns and resolve issues.
- Assists in 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.
- Performs responsibilities of a Complaint Handling Unit designee including containment, root cause analysis, corrective action, review and reporting for customer returns and complaints.
- Work with production to document current process parameters and develop written instructions to eliminate unnecessary process variation.
- Participates in pre- and post-production reviews providing quality engineering support.
- Supports measuring and analyzing key metrics to monitor performance.
- Perform necessary training related to CAPA’s and continuous improvement efforts.
- Mentors quality and production personnel on problem solving and proper inspection techniques.
- Works with cross-functional teams to solve production and quality problems.
- Back up the Quality Systems Specialist on Regulatory Release activities per FDA 21 CFR 820.80 (d) when required.
- At least 5 years of experience in Engineering
- Bachelor’s Degree in engineering or technical equivalent
- At least 5 years of experience in Quality Engineering
Education and Certification
- Certifications in ASQ, CQE
KNOWLEDGE, SKILLS AND ABILITIES
- Ability to apply logic and reasoning to solve complex problems, including identifying strengths/weaknesses and arriving at alternative solutions and conclusions
- Ability to apply the fundamental quality tools (ie. Pareto charts, cause and effect diagrams, 5-Why analysis) to define, analyze, and solve problems
- Print reading skills and thorough knowledge of Geometric Dimensioning & Tolerancing (GD&T) and the application of AMSE Y14.5M
- Ability to multi-task to meet tight time constraints in a fast paced environment and remain well organized
- Competent in Minitab or other software to analyze and understand data (capability studies, Gage R&R, ANOVA, etc.) and create actionable reports
- Ability to complete customer PPAP information
- Ability to conduct measurement correlation studies with the customer and capability studies internally
- Ability to create final inspection criteria
- Corrected 20/20 vision
- Constantly operates a computer
- Occasionally inspects product
ABOUT OUR VALUES AND LEADERSHIP COMPETENCIES
As a member of our team, leading from our values is foundational.
We Do the Right Thing
We Are All Connected
We Are Driven & Curious
- 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
The most important outcomes to drive in the next 1-2 years are:
- Improved customer quality rating
- Reduced scrap & rework
- Timely complaint resolution
This Job Description is only a summary of the typical functions of the job, not an exhaustive or comprehensive list of all possible responsibilities, tasks, and duties, and does not limit the assignment of additional duties for this position.
EOE, including disability/vets.