We Make Life More Rewarding and Dignified
Location: Ballina
Department:
The Senior Supplier Quality Engineer (SSQE) ensures that sourced materials, components, and services consistently meet quality, compliance, and business requirements. The role leads supplier qualification and ongoing performance management; drives resolution of incoming material issues; strengthens inspection strategies and test methods; and serves as the primary quality interface with suppliers and internal stakeholders.
Working cross‑functionally with Quality, Engineering, Manufacturing, Supply Chain, and Product Development, the SSQE applies statistical methods, risk‑based thinking, and problem‑solving tools to prevent defects, reduce cost of poor quality, and improve supplier capability. The position supports audits, change control, and continuous improvement to uphold an effective, compliant quality management system across the external supply base.
Responsibilities
- Lead timely containment, investigation (e.g., 5 Why/Is‑Is Not), and corrective and preventive actions (CAPA) for supplier‑related nonconformances and incoming material issues.
- Own supplier quality performance management: define expectations, monitor KPIs (e.g., incoming defect rate, on‑time NC closure), and facilitate reviews with suppliers and internal stakeholders.
- Plan, execute, and/or lead supplier quality system and process audits; track findings to effective closure and verify sustained effectiveness.
- Support new supplier selection and qualification, including technical assessments, validation/first article activities, and approval of quality agreements and control plans.
- Partner with Incoming Inspection to optimize sampling plans, measurement methods, and documentation; implement risk‑based reduced inspection where justified.
- Maintain and improve incoming test methods and inspection equipment in collaboration with Metrology/Engineering; ensure calibration and capability are in place.
- Facilitate Material Review Board (MRB) processes; disposition nonconforming product in accordance with procedures and regulatory expectations.
- Collaborate with Engineering/Manufacturing on specification clarity, drawing change control, and supplier change notifications to protect form/fit/function and compliance.
- Contribute to cost‑of‑quality reduction through scrap/rework avoidance, yield improvement, and supplier‑driven continuous improvement initiatives.
- Provide guidance and training on statistical techniques, measurement system analysis (MSA), and problem‑solving tools to internal teams and suppliers.
- Perform computer‑based work for extended periods; move between office, laboratory, and manufacturing areas in accordance with safety and quality requirements.
- Lead/facilitate meetings, audits, and supplier visits; prepare and present clear, data‑driven updates and recommendations.
- Handle samples, inspection fixtures, and measurement equipment; follow safe lifting and ergonomics practices.
- Occasional domestic/international travel may be required to supplier and company sites.
Essential Functions of the Role
Support audits and regulatory reporting as needed.
Follow standard operating procedures and safety regulations.
Education & Work Requirements
Bachelor’s Degree with 5-8 years of related experience
Education & Work Preferences
- Bachelor’s degree in Engineering or Science (e.g., Mechanical, Materials, Manufacturing, Chemical, Quality) or equivalent practical experience.
- Significant experience in supplier quality and/or quality engineering within a regulated manufacturing environment (medical device or similar), including supplier auditing and incoming quality control.
- Working knowledge of quality management system requirements and regulations relevant to medical devices (e.g., FDA 21 CFR Part 820/QMSR, ISO 13485) and application of risk‑based approaches.
- Demonstrated proficiency with statistical methods (sampling, SPC), problem‑solving and root cause analysis, and technical documentation/technical writing.
- Strong communication and collaboration skills with the ability to influence suppliers and cross‑functional partners; effective organization and attention to detail.
- ASQ certifications (e.g., Certified Quality Engineer \(CQE\), Certified Quality Auditor \(CQA\)) or ISO 13485 Lead Auditor credential.
- Experience conducting supplier process audits and process capability studies (e.g., MSA, Gage R&R, Cp/Cpk, PPAP/FAI).
- Knowledge of GMP expectations and familiarity with ISO 14971 risk management for medical devices.
- Background with plastics processes (e.g., injection molding, film sealing) and/or other relevant manufacturing processes.
- Experience with ERP/SAP and proficiency with Microsoft Office; exposure to Lean/continuous improvement methods.
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.
Job Req ID: 35854
