Lead Design Assurance Quality Engineer

Summary

The Lead Quality Engineer Design Assurance 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.  Hollister Incorporated operates in a Hybrid Environment. This position requires the Associate to be in the Kaunas, Lithuania office approximately 3 days per week.

The Lead Quality Engineer Design Assurance 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 Lead Quality Engineer Design Assurance 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.

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.
• Ownership of Usability Engineering Files for our devices.
• 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 (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.

Education & Work Requirements

Education & Work Preferences

• Experience in medical device industry.  Background in Quality Engineering and/or New Product Development/R&D.
• Further education may reduce number of years necessary.
• ASQ Certified Quality Engineer and/or ASQ Certified Reliability Engineer preferred
• Working Knowledge with Statistics and Statistical Tools (Statistica, Minitab, Excel)
• Knowledge of Validation and FMEA
• 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, human factors engineering and risk management for medical devices (ISO 14971).
• Desirable:  Advanced statistics training and experience with plastic injection molding and automated assembly processes.

Company offers:

• Learning and development-oriented culture
• Annual bonus based on personal performance
• A benefits package, including health insurance, to support your well-being
• Flexible working hours
• Fresh and healthy breakfast and lunch at our site's restaurant, available at an exclusive company price
• Team-building, summer festivals, and special events
• Free charging stations for electric cars
• 24/7 accident insurance.

We guarantee confidentiality and will inform only selected candidates.