Quality Engineer/Senior Quality Engineer Job Opening at Hollister Incorporated in Libertyville, IL

Quality Engineer/Senior Quality Engineer

For over 90 years, Hollister Incorporated has built a strong foundation of quality medical products, quality services, and quality employees - making a difference in the lives of those we serve. Hollister Incorporated stands strong: We are an independent and employee-owned company. Committed to our customers. Dedicated to our employees. Working towards the future with a long-term vision.

Our challenge at Hollister Incorporated is to find those who share this dedication of helping others. Those searching for a way to make a difference. To leave a legacy of achievement. Knowing it takes talent, teamwork, and sheer determination.

Hollister Incorporated is a company where dedicated professionals can channel their efforts in a worthwhile cause. A company where good work is rewarded. Where contributing selflessly is highly regarded. This growing global medical device company will make the journey...with you. So join us, and make a difference.

Department: Global Quality Management

Reports to: Sr Manager Quality Engineering

Travel: up to 15%

Summary

The Quality Engineer functions as a project core team member, representing Quality Management on new product development projects, committing to support product / project objectives, driving and participating in business decisions, and assuming accountability for product / project success. The Quality Engineer also serves as an interface between a cross-functional extended core team and the project core team leader on new product development projects.

The position works under supervision on technical quality related tasks, provided with techniques and procedures, applying judgment to details of work and in making preliminary selections or adaptations of quality alternatives. The position develops realistic action steps, timetables and resource estimates for global or plant projects, and may work as project lead on smaller projects. The position also supports quality management in establishing goals and strategies, and implements quality projects and reviews the results with appropriate customers.

Responsibilities

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

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

• 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.

• Support the Hollister corporate facility quality management system.

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

Qualifications

Academic/Credentials/Certifications:

• Bachelor of Science degree or higher in Engineering or Physical Sciences
• ASQ Certified Quality Engineer and/or ASQ Certified Reliability Engineer required
• ASQ Certified Manager of Quality / Operational Excellence or Six Sigma Black Belt certificate is a plus

Length of Experience:

• Minimum of three (3) years relevant experience

Specialized Skills/Technical Knowledge:

• Experience with the FDA Quality System Regulation and ISO 13485 environment at a medical device manufacturer is required.
• Experience with product development and design controls, as well as risk management for medical devices (ISO 14971) is also required.
• Advanced statistics training and project management experience is a plus.

*Hollister is an Equal Opportunity Employer.