Terumo Medical Corporation Sr. Supplier Quality Engineer in Elkton, Maryland
This associate is responsible for implementing the supplier management process. This includes:
Review of all new supplier add requests for impact on quality system and required controls
Assess the suitability of suppliers to meet requirements through supplier evaluation, including supplier questionnaires, quality agreements and supplier site evaluations.
Work closely with suppliers and R&D, Supply Chain and Quality Engineering groups to ensure potential suppliers for development projects meet requirements for qualification.
Facilitating and performing component/material qualifications
Assists in the development of DFEMA’s (Design Failure Mode Effect Analysis) and PFMEA’s (Process Failure Mode Effect Analysis) and control plans where required.
Facilitating validations and component acceptance activities
Identifying when gage r & r studies are needed
Ongoing supplier management activities
Building relationships with suppliers to ensure that purchased components meet specifications
Drives continuous improvement in supplier performance through utilization tools such as Six Sigma DMAIC, FMEA, SPC, 8D Root Cause Analysis and Lean Manufacturing concepts.
Optimize process capability on significant characteristics through effective application of statistical analysis techniques and training of Suppliers in problem-solving. Provide expert analysis, guidance and support to Suppliers in Process Improvement.
Utilize analytical skill sets to implement root-cause analysis and provide recommendations for corrective action.
Drives Supplier actions to verify component and process quality at the Supplier’s location to reduce the need for incoming inspection activities.
Manage the Supplier Corrective Action Request process.
Trending of supplier metrics
Maintains and analyzes Key Performance Indicators (KPIs) and Cost of Poor Quality data to identify recurring trends and drives improvement actions to reduce internal and external failure costs.
Work with suppliers and Supply Chain to establish and manage continuous improvement programs including supplier ratings and supplier score cards.
Manage databases and files containing information supporting the suitability of suppliers to provide components and services. Maintain accessible records for internal and third-party audits.
Generate a monthly Supplier Performance Report including input from discrepancy reports and supplier ratings.
This associate is responsible to stay current with FDA and International requirements and industry trends in regards to regulations and expectations for industry.
Qualifications Position Requirements:
Knowledge, Skills and Abilities (KSAs)
Knowledge of medical product manufacturing and development
Solid understanding of receiving inspection processes including statistical sampling, component measurement techniques, specifications and drawings
Thorough working knowledge of Quality systems methods and practices (DOE, PFMEA, Control Plans, Lean Manufacturing concepts, DMAIC, Root Cause Analysis, etc.).
Ability to understand the technology related to TMC’s products
Good interpersonal and communication skills
Understanding of CAPA and closed loop corrective action
Strong technical business writing and oral communication skills.
Proficient in spreadsheet (report formatting, graphing, formula a calculation generation), database, presentation and project management tools.
Bachelor’s or advanced degree in related engineering field or equivalent.
Minimum of seven years of related experience in supplier approval / management
Certification as a Quality Engineer or Quality Auditor by the American Society for Quality
Trained in Six Sigma and Lean methodology; certified as well
Experience working with suppliers on medical product quality issues
Experience evaluating suppliers including on-site auditing
Title Sr. Supplier Quality Engineer
Auto req ID 5492BR
Affirmative Action/Equal Employment Opportunity Statement
It is the Company's policy to provide equal employment opportunity to all its employees and applicants for employment regardless of their race, creed, color, national origin, age, ancestry, nationality, marital or domestic partnership or civil union status, sex, pregnancy, gender identity or expression, disability status, liability for military service, protected veteran status, sexual orientation, atypical cellular or blood trait, genetic information (including the refusal to submit to genetic testing), or any other category protected by law. As a Company, we value diversity of background and opinion, and prohibit discrimination or harassment on the basis of any legally protected class in the areas of hiring, recruitment, promotion, transfer, demotion, training, compensation, pay, fringe benefits, layoff, termination or any other terms and conditions of employment. In compliance with the Americans with Disabilities Act (ADA), if you have a disability and would like to request an accommodation with regard to the application and selection processes (for example, the online application process or interviews) or have any questions about our website accessibility, please call 732-302-4902 or e-mail us at Staffing@Terumomedical.com.