Supplier Quality Engineer - Diverse Lynx
Memphis, TN
About the Job
Job Title: Supplier Quality Engineer
Location: Memphis, TN//Onsite
Duration: Full Time-Only
JOB DESCRIPTION:
Technical/Functional Skills
" Medical Device Domain Experience
" Good understanding of ISO 13485, ISO19471, 21CFR PART 11 & 21CFR PART 820
" Knowledge of Gage R&R, QFD, MSA, AAA, Hypothesis Testing, RISK Mitigation, P-FMEA, Control Chart-Variable & Attributes
" Knowledge of Validation and verification activities (IQ/OQ/PQ)
Experience Required
" Bachelor s Degree in engineering or Technical Field or equivalent combination of education and work experience
" Min 3 years of related experience
" Demonstrated supervisory experience preferred. Engineering experience and demonstrated use of Quality tools/methodologies.
" Detailed knowledge of FDA, GMP, ISO 13485, and ISO19471, 21CFR PART 11 & 21CFR PART 820.
" Good communication and interpersonal skills.
" Strong project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner.
" Advanced computer skills, including statistical/data analysis and report writing skills.
" Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing).
" ASQ CQE or other certifications preferred.
" Experience working in a broader enterprise/cross-division business unit model preferred
Diverse Lynx LLC is an Equal Employment Opportunity employer. All qualified applicants will receive due consideration for employment without any discrimination. All applicants will be evaluated solely on the basis of their ability, competence and their proven capability to perform the functions outlined in the corresponding role. We promote and support a diverse workforce across all levels in the company.
Location: Memphis, TN//Onsite
Duration: Full Time-Only
JOB DESCRIPTION:
Technical/Functional Skills
" Medical Device Domain Experience
" Good understanding of ISO 13485, ISO19471, 21CFR PART 11 & 21CFR PART 820
" Knowledge of Gage R&R, QFD, MSA, AAA, Hypothesis Testing, RISK Mitigation, P-FMEA, Control Chart-Variable & Attributes
" Knowledge of Validation and verification activities (IQ/OQ/PQ)
Experience Required
" Bachelor s Degree in engineering or Technical Field or equivalent combination of education and work experience
" Min 3 years of related experience
" Demonstrated supervisory experience preferred. Engineering experience and demonstrated use of Quality tools/methodologies.
" Detailed knowledge of FDA, GMP, ISO 13485, and ISO19471, 21CFR PART 11 & 21CFR PART 820.
" Good communication and interpersonal skills.
" Strong project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner.
" Advanced computer skills, including statistical/data analysis and report writing skills.
" Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing).
" ASQ CQE or other certifications preferred.
" Experience working in a broader enterprise/cross-division business unit model preferred
Diverse Lynx LLC is an Equal Employment Opportunity employer. All qualified applicants will receive due consideration for employment without any discrimination. All applicants will be evaluated solely on the basis of their ability, competence and their proven capability to perform the functions outlined in the corresponding role. We promote and support a diverse workforce across all levels in the company.
Source : Diverse Lynx