| We are looking for experienced Quality Engineers in either New Product Introduction or Sustaining Product Quality at our multiple sites. Locations include Michigan (Lansing, Bridgeport, Detroit), California (Arcadia and Santa Ana), Alabama and Oregon. 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 The Quality Engineer, New Product Introduction works with project management and manufacturing engineers to support new product introductions and ongoing validation. The Quality Engineer, Sustaining Product Quality supports the ongoing quality of Orchid’s legacy products. 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.
- 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
- Monitors engineering processes and products for adherence to company and regulatory standards and practices. Participates in quality improvement initiatives and projects.
- Performs quality reviews and internal audits; evaluates data and writes reports to validate or indicate deviations from existing standards.
- Analyzes statistical data and product specifications to determine standards and establish quality and reliability objectives for Orchid.
- Recommends modifications to existing quality or production standards to achieve optimum quality within limits of equipment capability.
- Determines machine and process capabilities and performance reliability by conducting capability studies.
- Determines criteria for boundary sampling.
- Conducts special process validations and equipment validations including installation qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- 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.
- Interfaces with appropriate customer contacts to clarify customer requirements to include cosmetic specifications.
- Develops inspection criteria that correlate customer requirements and manufacturing processes that include identification of characteristics, sampling plans, and gauging. This also includes the guidance into the control plans and will be the final reviewer for all control plan documentation.
- Assists suppliers with the interpretation of quality requirements.
- Lead quality and compliance by 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.
EXPERIENCE - At least 2 years of engineering experience
- Experience in medical devices manufacturing preferred
KNOWLEDGE, SKILLS AND ABILITIES - Ability to apply logic and reasoning to solve complex problems, including identifying strengths/weaknesses, locating alternative solutions and conclusions, and approaches to problems; and making high-quality, timely decisions
- Knowledge of quality management methods, tools, and techniques used to create and support an environment that meets the needs of the organization
- Knowledge and understanding of federal, state and local laws and regulations affecting manufacturing practices and activities
- Ability to proof read data
- Knowledge of procedures and tools for scheduling and controlling production runs and assuring quality deliverables
- Ability to complete customer PPAP information
- Ability to conduct measurement correlation studies with the customer
- Ability to create final inspection information
EDUCATION AND CERTIFICATION - Bachelor's Degree in mechanical engineering or related field required
- GD&T Certification preferred
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