Senior Design Assurance Quality Engineer I-II

Hollister Incorporated; Libertyville (IL); Hybrid; USD 90,000 - 125,000; Full time

Job summary

Hollister Incorporated in Libertyville, IL seeks a Sr. Design Assurance Quality Engineer to support new product development and change management. You will lead design controls, risk assessments, verification/validation, and cross‑functional quality activities to ensure product success.

The role requires 5–8 years of related experience, ASQ credentials preferred, and a strong background in ISO 13485 medical device environments. Hybrid work and in‑office collaboration are expected.

Qualifications

• Bachelor's degree with 5-8 years of related experience.
• ASQ Certified Quality Engineer and/or ASQ Certified Reliability Engineer preferred.
• ASQ Manager of Quality / Operational Excellence or Six Sigma Black Belt a plus.
• Experience with ISO 13485 environment in medical devices.
• Professional proficiency in English.
• Experience with design controls and product development.
• Project management training and experience.

Responsibilities

• Guide cross-functional teams in applying design controls per ISO/regulatory requirements.
• Facilitate design verification/validation and risk assessments (ISO 14971).
• Lead or support design FMEA and process FMEA activities.
• Interface with site and supplier Quality teams on new products/changes.
• Apply statistical methods (ANOVA, DOE, control charts) to qualify processes.
• Support audits, reviews, and regulatory submissions as needed.

Skills

Design controls

Quality Engineering

FMEA

Statistics

Education

Bachelor's Degree

Tools

Excel

SAP

Minitab

Statistica

Job description

We Make Life More Rewarding and Dignified

Location: Libertyville

Department: Quality

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.

Hollister Incorporated operates in a hybrid work environment. Employees are expected to come into the office a minimum of 4 days per week. Sponsorship to work in the US is not available at this time.

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

• 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.
• Resolve inquiries and issues with professionalism and discretion.
• 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.

Education & Work Requirements

• Bachelor's Degree with 5-8 years of related experience

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
• Candidates with over 8 years of experience may be considered for a Lead Design Assurance Quality Engineer role.

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.

Our Total Rewards package in aggregate is above market and includes competitive pay, paid time off programs, peer-to-peer recognition, health and life insurance, wellness programs and incentives, and generous retirement savings.

• The anticipated base pay range for this position is $90,000 - $125,000 yearly. The actual salary varies based on applicant's location, education, experience, skills, abilities, and other legitimate business factors.
• This position is also eligible to participate in the Hollister Corporate Bonus Plan.
• The Company's health and welfare benefits include medical, prescription, dental, vision, spending/savings accounts, disability, company paid (parental and caregiver) leaves, statutory leaves/disability programs, accident, life, wellbeing, education assistance, adoption assistance, and voluntary benefit programs.
• The Company's 401(k) Retirement Savings Plan includes: auto-enrollment, ROTH, vesting and eligible participants "safe harbor" matching contributions.
• The Company's paid time off benefits include: 11 paid holidays, paid vacation based on length of service and exempt/non-exempt status, and sick days based on statutory requirements and/or exempt/non-exempt status.
• The Company's additional benefits include: education assistance and adoption assistance benefit programs.

About Hollister Incorporated

Hollister Incorporated is an independent, employee-owned company that develops, manufactures and markets healthcare products worldwide. The company spearheads the advancement of innovative products for ostomy care, continence care and critical care, and also creates educational support materials for patients and healthcare professionals. Headquartered in Libertyville, Illinois, Hollister has manufacturing and distribution centers on three continents and sells in nearly 80 countries. Hollister is a wholly owned subsidiary of The Firm of John Dickinson Schneider, Inc., and is guided both by its Mission to make life more rewarding and dignified for people who use our products and services, as well as its Vision to grow and prosper as an independent, employee-owned company, and in the process, to become better human beings.

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.