Design Assurance Quality Engineer

6.00 to 9.00 Years HARYANA (Haryana) 18 Apr, 2019

Job Location	HARYANA (Haryana)
Education	Any Graduate
Salary	Rs 8.00 - 10.00 Lacs p.a.
Industry	Engineering/Projects
Functional Area	Quality/Process Control
EmploymentType	Full-time

Job Description

About the company: HollisterAn American MNC that develops, manufactures, and markets healthcare products and services worldwide.They offer advanced medical products for Ostomy Care, which include strong global brands Dansac Ostomy; Continence Care; and Critical Care. They also provide innovative healthcare programs and services, as well as educational materials for patients and healthcare professionals.They have been serving healthcare professionals and patients for more than 95 years making a difference in the journey of life.Responsibilities:

Guide cross-functional teams in the appropriate application of design controls in compliance with global regulatory requirements for medical devices.

Facilitate project quality activities addressing design and process verification / validation for new products and significant changes to existing products or processes.

Facilitate design FMEA with the help of corporate functions, Lead in process FMEA, and conduct risk assessments in compliance with ISO 14971.

Interface with corporate functions and Plant Quality Assurance for new products and significant changes to existing products or processes.

Utilize parametric and nonparametric statistical analysis methods (ANOVA, DOE, hypothesis testing, power analysis, process capability analysis, quality control charts, regression analysis, survival analysis, measurement system analysis, acceptance sampling ANSI/ASQ Z1.4 & Z1.9) to ensure products/processes are appropriately characterized and qualified prior to market release.

Support review of Preproduction and First Article submissions from the plant and suppliers for new products and significant changes to existing products or processes. Participate in internal, supplier, and external regulatory agency audits / inspections as required.

Develop Design History files for compliance to applicable Regulatory Standards and submissions.

Keyskills :
Quality AssuranceProject ManagementSix Sigma Black BeltDesign ControlMedical DevicesNew Product Development

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