Lead Design Assurance Quality Engineer

Date: Jul 23, 2026

Location(s):

Ballina, MY, IE, F26 F3X5

Location(s):

Ballina, MY, IE, F26 F3X5

Company: Hollister ULC

We Make Life More Rewarding and Dignified

Location: Ballina
Department: Quality

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.

Essential Functions of the Role

Communicate effectively via email, phone, and virtual platforms.
Collaborate across departments to support organizational goals.
Participate in cross-functional meetings and initiatives.
Maintain and analyze data using tools like Excel, SAP, or HRIS systems.
Prepare reports and dashboards for internal stakeholders.
Ensure data accuracy and confidentiality in compliance with company and legal standards.
Manage multiple priorities and deadlines in a fast-paced environment.
Lead or support special projects aligned with departmental objectives.
Demonstrate initiative in identifying process improvements or automation opportunities.
Serve as a point of contact for internal and external stakeholders.
Adhere to company policies, including those related to ADA, data privacy, and ethics.
Maintain secure handling of sensitive information.
Support audits and regulatory reporting as needed.
Oversight of compliance, risk, and organizational culture.

Education & Work Requirements

Bachelor’s Degree with 8-12 years of related experience

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.

Competencies

Be Agile - Innovates and adapts quickly, approaching change with curiosity while persisting through obstacles.
Be Customer Centric - Considers the needs, experiences and feedback of customers in all we do.
Be People-Focused - Builds trust and collaborates with an inclusive and empathetic approach.
Be Performance Driven - Operates with an ownership mindset, driving meaningful outcomes.
Live The Schneiders’ Legacy, Our Noble Purpose - Passionately serves Our Mission and Vision, while demonstrating the Immutable Principles.

EOE Statement
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Job Req ID: 36391