Senior Design Assurance Quality Engineer II

Summary

The Sr. Design Assurance Quality Engineer functions as a project core team member, representing Global Quality and Regulatory Affairs (GQRA) on new product development and change management projects committing to support product/project objectives, driving and participating in business decisions, and assuming accountability for product/project success.

The Sr. Design Assurance Quality Engineer also employs project management methods to serve as an interface between the GQRA extended core team and the project core team leader on new product development projects. The position independently evaluates, selects and applies standard quality techniques, procedures and criteria, using judgment in making decisions on clear and specified objectives, and implements best practice procedures to clarify work processes.

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, participate in process FMEA, and conduct risk assessments in compliance with ISO 14971


• Support Specification and Test Method Development, Clinical, Design Verification and Validation


• Interface with Hollister plant and supplier Quality Engineering and Quality Assurance for new products and significant changes to existing products or processes


• Utilize parametric and nonparametric statistical analysis methods (including ANOVA, DOE, hypothesis testing, power analysis, process capability analysis, control charts, regression analysis, survival analysis, MSA, 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 submissions from the Hollister plants and suppliers for new products and significant changes to existing products or processes


• Strong knowledge of subject matters related to principles and practices of Quality Engineering


• Participate in internal, supplier, and external regulatory agency audits / inspections as required

Essential Functions of the Role

Education & Work Requirements

Education & Work Preferences

• ASQ Certified Quality Engineer and/or ASQ Certified Reliability Engineer strongly preferred

ASQ Certified Manager of Quality / Operational Excellence or Six Sigma Black Belt certificate is a plus

• Background in Quality Engineering and/or New Product Development/R&D


• Working Knowledge with Statistics and Statistical Tools (Statistica, Minitab, Excel)


• Knowledge of Validation processes and FMEA creation


• Professional proficiency in English


• Experience with Design Controls and/or product development


• Experience with the EU MDD/MDR directives and regulations and ISO 13485 environment at a medical device manufacturer


• Project management training and experience


• Experience with product development, design controls, and risk management for medical devices (ISO 14971)


• Minitab, Stature experience preferred

Competencies