Quality Engineer Sustaining Product Quality (Arab)

Quality Engineer Sustaining Product Quality

Position DescriptionABOUT ORCHIDOrchid Orthopedic Solutions is a worldwide leader in design and manufacturing for the orthopedic and medical device markets including joint reconstruction spi ne 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 five countries - US UK Swit zerland China and India.Additional information on the company can be found at www.orchid-ortho.com.SUMMARY OF POSITIONThe Quality Engineer Sustaining Product Quality supports the ongoing quality of Orchid s legacy products. This position reports directly to the Manager Product Quality .KEY JOB RESPONSIBILITIESUses 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 . 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 standar ds. Conducts process and equipment validations. Acts as a customer liaison and 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. Reviews and approves 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 quality and compliance by utilizing One Orchid global processes and complying with all Quality Management Systems (QMS) documentation requirements and establishing supporting plan(s) to meet exceed Key Performance Indicators (KPls) for Quality that support Safety Compliance Six Sigma Quality On-Time Delivery (OTD) and financial objectives. EXPERIENCE3 years of full-time professional engineering experience required Experience in medical devices manufacturing preferred KNOWLEDGE SKILLS AND ABILITIESAbility 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 CERTIFICATIONBachelor s Degree in mechanical engineering or related field preferred. GD& T Certification preferred CQE CRE CQA CQM or other quality certification preferred. ABOUT OUR VALUES AND LEADERSHIP COMPETENCIESAs a member of our team leading from our values is foundational.Values Integrity First We Do the Right Thing Teamwork We Are All Connected Relentless Pursuit We Are Driven & Curious EOE Vet Disability