Supplier Quality Engineer

Summary:

The Supplier Quality Engineer ensures suppliers deliver quality products on an ongoing basis while developing supplier capability for future needs. This role represents Supplier Quality on development, manufacturing, and product improvement projects. The Supplier Quality Engineer will be a part of the Quality Organization and report to the Manager of Global Supplier Quality. The Supplier Quality Engineer will work with cross-functional teams, develop supplier capabilities, execute supplier selection and approval, material qualification, material control, and supplier development activities. This includes qualifying suppliers according to company standards. Provides technical guidance on resolving quality problems on supplied production material.

This role includes operating as a core member (or leader) of project teams for new product development and change implementation. Evaluate and manage suppliers, aid by identifying quality improvement initiatives and cost savings.  Address quality concerns for current products, development opportunities, and process improvements that positively impact the Hollister Quality Management System.  Partner with the cross-functional team members to achieve Quality objectives compatible with Hollister Mission and Vision.

Responsibilities:

• Drive Supplier selection and evaluation process of new and existing suppliers.
• Execute quality agreements and perform audits as part of initial assessment and ongoing management of Supplier relationships; ensure compliance with relevant quality system regulations.
• Act as primary quality contact with suppliers, working with them to solve issues that arise and recommend improvements. 
• Represents Supplier Quality on product development and participate in the selection of material suppliers.
• Complete investigations of nonconforming materials to understand the root cause of failure driving corrective actions internally and externally with suppliers. 
• Monitor supplier quality performance metrics and drive resulting corrective/preventive actions determined to be necessary. 
• Actively help maintain and improve a Quality System compliant with FDA regulations and ISO 13485 (e.g., training documents, procedures, work instructions, specifications, labeling).
• Assist in any external regulatory audits (FDA, notified body) in support of the Hollister Quality Management System.
• Interface with internal functions, such as Design Assurance, Global Engineering, and R&D, on new product development projects and significant changes related to supplier processes.
• Support development and maintenance of Design History File (DHF) and Technical Files for Hollister-owned design and private label products.
• Utilize understanding of statistical analysis methods (ANOVA, Hypothesis testing, process capability analysis, DOE, GR&R, survival analysis, measurement system analysis, etc.) to ensure that manufacturing processes are appropriately qualified, and requirements are met prior to commercialization. 
• Evaluates suppliers’ internal functions to assess their overall performance and provide feedback through quality tools such as 8D process, cause, and effect diagrams, FMEA, SPC, DOE, and GR&R
• Execute supplier management plans to improve supplier and product performance, including site visits to resolve product performance concerns.
• Support the development of an auditing schedule to ensure that designated suppliers are audited on a regular basis and quality standards (ISO procedures) are met.
• Participate in design reviews for product and/or components and assures that suppliers are involved early in the process.
• Utilize project management skills to lead root cause investigations and quality improvement initiatives with key suppliers. Collaborating with cross-functional technical community (Manufacturing, Engineering and R&D) and suppliers, whilst communicating progress to all levels of the organization with a focus on business impact.
• Identify and implement cost savings opportunities by partnering with Operations and Engineering
• Mentor and train others on subject matters related to the certified quality engineering body of knowledge and manufacturing principles and practices.
• Other duties as assigned.
• This role is hybrid, 3 days in the office; however, the associate should be willing to attend meetings, participate in projects, or join events at the Libertyville, IL office when required.

Essential Functions of the Role**:

• Work in an office environment is required as well as in labs and manufacturing sites.

Work Experience Requirements

• Minimum 5 years overall experience is required.
• Minimum of 3-5 years’ experience in a Quality Engineering (or equivalent industry discipline) required.
• Experience supporting new product design and interacting with supply base to assure successful outcomes (Design Controls) is required.
• Experience in Medical Device Manufacturing in compliance with applicable foreign and domestic regulations including US FDA 21 CFR Part 820, ISO 13485, EU Medical Device Regulation.
• Professional designations are not required, but training and certificates in quality or regulatory affairs would be a plus (e.g., CQM, CQE, CQA, RAC, CLIA, Six Sigma, Lean Principles).

Education Requirements

• Bachelor's degree is required; Engineering, Math, Physical Sciences, Computer Science or related study is preferred.
• Master’s Degree preferred

Specialized Skills/Technical Knowledge:

• ASQ Certified Quality Engineer highly desired
• Knowledge and experience in statistical software packages (ex. Minitab) for data analysis
• Good project management 
• ASQ Certified Quality Auditor or Recognized Lead Auditor Certification Program
• Basic technical writing skills required; advanced technical writing skills preferred.
• Knowledge of SAP/ERP Systems a plus
• Ability to train / facilitate others inside and outside of the company.
• Good communication skills, both written and oral, to an international supply base with varied cultural expectations
• Experience supporting new product design and interacting with supply base to assure successful outcomes (Design Controls) is required.
• Experience using quality tools, for example, Failure Modes and Effects Analysis (FMEA), Statistical Process Control (SPC), Design of Experiments (DOE), Gage Repeatability and Reproducibility (GR&R) and Weibull Analysis
• Good understanding of materials and manufacturing processes
• Familiar with problem-solving techniques and conflict resolution techniques.
• Good understanding of quality systems methodology and applications, especially those related to medical device manufacturing (Nonconforming product, Post-launch Design Change, CAPA).
• Ability to travel domestically/internationally 20-30%

Local Specifications (English and Local Language):

• Ability to read, understand and speak English fluently.