The Design Assurance Quality Engineer functions as a project core team member, representing Quality Management 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 Design Assurance Quality Engineer also employs project management methods to serve as an interface between a cross-functional 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 will implement best practice procedures to clarify work processes. The Design Assurance Quality Engineer will also take leadership roles in projects and programs, create teams, and establish objectives for the team. In ensuring that team objectives are met, the position will identify specific action steps and accountabilities, clarify roles and distribute work load and responsibilities to appropriate individuals. The position will monitor progress of others and redirect their efforts when goals are not being met.
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.
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 (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 Hollister plants and suppliers for new products and significant changes to existing products or processes.
Mentor and train others on subject matters related to principles and practices of Quality Engineering.
Participate in internal, supplier, and external regulatory agency audits / inspections as required.
Number of Overall Years Necessary: 5-8
Experience with the FDA Quality System Regulation and ISO 13485 environment at a medical device manufacturer. Background in Quality Engineering and/or New Product Development/R&D.
Bachelor of Science degree or higher in Engineering or Physical Sciences
ASQ Certified Quality Engineer strongly preferred
Six Sigma Black Belt certificate is a plus
Experience with project management, product development, design controls, and risk management for medical devices (ISO 14971).
Desirable: Advanced statistics training and experience with plastic injection molding and automated assembly processes.
Hollister Incorporated is an independent, employee-owned company that develops, manufactures, and markets products for ostomy care, continence care, and critical care and develops educational support for patients and healthcare professionals. We have been in business for more than 95 years. Our products are sold in more than 90 countries and we have manufacturing and distribution centers on three continents. At Hollister Incorporated, we are passionate about the work we do, and we are committed to making life more rewarding and dignified for our Associates and for the people who use our products and services. A career at Hollister Incorporated can take many paths, all of them leading to rewarding opportunities.
Telecommuting is allowed.
Internal Number: 27446
About Hollister Incorporated
Hollister Incorporated is an independently-owned global company that develops, manufactures and markets healthcare products, servicing over 90 countries. From the earliest days of our company, there has been a strong sense of community—a connection to people. That connection is embedded in the very fabric of our company, and as we continue to develop new products and services, we are focused on meeting the healthcare needs of people throughout the global community.