PRINCIPLE ACCOUNTABILITIES:

• Develops and initiates standards and methods for inspection, testing and evaluation
• Devises sampling procedures and designs and develops forms and instructions for recording, evaluating and reporting quality and reliability data
• Develops and implements methods and procedures for disposition of discrepant material and devises methods to assess cost
• Directs workers engaged in measuring and testing product and tabulating data concerning materials, product or process quality and reliability
• Compiles and writes training material and conducts training sessions on quality control activities.
• Holds up Product Engineers and Quality Program Managers with customer interfaces as necessary on quality related issues
• Assures data availability and integrity for all quality related data. Consolidates and reports on quality results
• Initiates corrective action requests as needed and tracks to satisfactory completion.
• Assists with development and implementation of quality audits
• In charge of developing, applying, revising and maintaining quality standards for processing materials into partially finished or finished products
• Designs and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and/or production equipment
• Explores reports and returned products and recommends corrective action
• Establishes program to evaluate precision and accuracy of production equipment and testing, measurement and research of equipment and facilities
• Approves product, process and equipment qualifications
• Provides liaison to various regulatory bodies

MEDICAL INDUSTRY KNOWLEDGE AND EXPERIENCE ON:

• IDE and Clinical trials applications in accordance with MDD Annex X, ISO 14155 standard
• Proficient knowledge of medical device regulations (21CFR), FDA law, MDD, other global laws and regulations and standards including ISO14971, IEC 60601 and related particular standards
• An excellent understanding and practical application of medical device quality system regulations, e.g., 21 CFR 820, ISO 13485 and ISO 14971

MEDICAL INDUSTRY QUALIFICATIONS:

• Technical training and experience using Statistics, Lean and Six Sigma Methodologies is required Experience in Measurement System Analysis, SPC, DOEs, Reliability,
• Experience working in both an FDA and European regulatory environment
• ASQ CQE, CRE, CSQE certification desirable

EDUCATION

Bachelor’s degree in related field or equivalent experience

Maintains quality engineering programs, standards and improvements within the organization.