Job Summary

A Quality Engineer supporting the Supplier Management process works closely with Manufacturing, R&D, Supply Chain, and Quality Engineering groups to ensure that the suppliers and the related purchased components or services meet specifications and other requirements.

Job Details/Responsibilities

1. This associate is responsible for implementing the supplier management process. This includes:
a. Review of all new supplier add requests for impact on quality system and required controls
i. Assess the suitability of suppliers to meet requirements through supplier evaluation, including supplier questionnaires, quality agreements and supplier site evaluations.
ii. Work closely with suppliers and R&D, Supply Chain and Quality Engineering groups to ensure potential suppliers for development projects meet requirements for qualification.
b. Facilitating and performing component/material qualifications
i. 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.
ii. Facilitating validations and component acceptance activities
iii. Identifying when gage r & r studies are needed
c. Ongoing supplier management activities
i. Building relationships with suppliers to ensure that purchased components meet specifications
ii. Drives continuous improvement in supplier performance through utilization tools such as Six Sigma DMAIC, FMEA, SPC, 8D Root Cause Analysis and Lean Manufacturing concepts.
iii. 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.

Job Responsibilities (continued)

iv. Utilize analytical skill sets to implement root-cause analysis and provide recommendations for corrective action.
v. Drives Supplier actions to verify component and process quality at the Suppliers location to reduce the need for incoming inspection activities.
vi. Manage the Supplier Corrective Action Request process.

d. Trending of supplier metrics
i. 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.
ii. Work with suppliers and Supply Chain to establish and manage continuous improvement programs including supplier ratings and supplier score cards.
iii. 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.
iv. Generate a monthly Supplier Performance Report including input from discrepancy reports and supplier ratings.

2. This associate is responsible to stay current with FDA and International requirements and industry trends in regards to regulations and expectations for industry.

Knowledge, Skills and Abilities (KSA)

o Knowledge of national and international regulations applicable to medical devices including; Quality System Regulations, 21 CFR 820, 21CFR 803 and 804 (MDR regulations), Canadian Medical Device Regulations, ISO 14971, ISO 13485, and MDD 93/42/EEC
o Certification as a Quality Engineer (CQE) or Quality Auditor by the American Society for Quality (CQA)
o Trained in Six Sigma and Lean methodology; Greenbelt certification preferred
o Thorough working knowledge of Quality systems methods and practices (DOE, PFMEA, Control Plans, Lean Manufacturing concepts, DMAIC, Root Cause Analysis, CAPA, etc.)
o Experience working with suppliers on medical product quality issues
o Knowledge of medical product manufacturing and development
o Solid understanding of receiving inspection processes including statistical sampling, component measurement techniques, specifications and drawings
o Ability to understand the technology related to TMC’s products
o Organizational skills as well as time management skills essential for project work
o Strong technical business writing, oral communication skills, and interpersonal skills
o Strong mathematics and statistics skills
o Proficient in spreadsheet (report formatting, graphing, formula a calculation generation), database, presentation and project management tools

Qualifications/ Background Experiences

• Requires a minimum of a 4 year degree in engineering, life sciences or a combination of prior work experience, education or combination thereof.
• Minimum of three years of related experience in supplier quality engineering, prefer three years of on-site auditing experience