Manager, Quality Assurance

NOTE: Those without experience in the medical device or pharmaceutical industry need not apply.

POSITION SUMMARY

Plans and directs activities concerned with the development of new products and the application and maintenance of quality standards for design controls and design transfer. Leads department and projects where extensive experience is required.



PRINCIPAL RESPONSIBLITIES include the following.
Other duties may be assigned.

 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. Establishes program to evaluate precision and accuracy of prototype equipment and testing, measurement, and analytical equipment. Develops and implements methods and procedures for disposition of prototype materials and devises methods to assess compliance. Reviews measuring and testing of products developed under Good Laboratory and Data Practices as well as analyzes and tabulates data concerning materials, product, or process quality and reliability. Compiles and writes training material and conducts training sessions on quality assurance activities and data practices. Conducts new supplier and internal design controls audits as Lead Auditor. Interacts with customers and suppliers routinely to ensure that product design and development compliance with applicable regulatory and internal/external standards are constantly maintained.  Addresses all product development issues for current products. Regulatory Affairs & Quality Assurance Leadership back-up, participation in design meetings, FMEA (product & process), development plans, test plans and design transfer. Leads and mentors Engineering staff to ensure continuous improvement in processes, materials, and products.

PROBLEM SOLVINGPossesses and applies comprehensive knowledge of quality assurance to the completion of significant assignments. Ability to multi-task significant projects with complex scheduling of key QA resources and deliverables. Possesses and applies a broad knowledge of principles, practices, and procedures of Quality Assurance to the completion of difficult assignments.

 

ACCOUNTABILITY/DECISION MAKINGWorks with minimum supervision, conferring with superior only on unusual matters. Has appreciable latitude for unreviewed action or decision.

 

SUPERVISORY RESPONSIBILITIESMinor supervisory responsibility as part of adherence to Good Laboratory and Data Practices.

 

EDUCATIONFour-year degree (Bachelor’s in engineering or science). Masters level in Quality, Organizational Development, or Quality related Engineering discipline.

 

EXPERIENCEFive years minimum in FDA/GMP/Quality Systems and/or ISO 13485 environment. Two years experience in New Product Development (NPD) and design verification / validation methods. Risk assessment, reliability, design verification, design validation and biostatistics preferred.

 

CERTIFICATES, LICENSES, REGISTRATIONSASQC CQE certification preferred. Six Sigma experience, Green Belt preferred.

 

TECHNICAL SKILLSAbility to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations.  Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.

 

COMMUNICATIONS SKILLSAbility to write routine reports and correspondence. Ability to communicate effectively before groups of customers or employees.