Quality Specialist

This is a full-time position ON-SITE in Rantoul, IL - not hybrid or remote

The Quality Specialist (QS) works with the internal manufacturing engineers, supply chain and contract manufacturers to continuously improve performance of key system components (refine life cycle, reduce scrap, improve/repair processes) by implementing process controls and developing quality control plans. Responsible for the overall Quality, Risk, and Performance Management of suppliers and contract manufacturers. The QS tracks data, identifies improvement projects, and manages cross functional implementation to improve performance in Production and Supplier Quality. The QS has high upstream focus to limit cost and time investment maximizing Product Quality. Does not have any direct reports.

Essential Duties And Responsibilities

• Maintain cooperative, diplomatic working relationships with co-workers, supervisor and the public.
• Work as part of the team and collaborate with co-workers and colleagues.
• Responsible for reading, understanding and following Quality Management Systems documentation for each function performed.
• Responsible for working in compliance with Quality Systems Regulations (QSR), safety and all other training.
• Provide feedback and recommendations for company improvement opportunities.
• Adhere to and support Combe’s Corporate Policies and Procedures.
• Actively works to improve processes in the company and its relationship to the community.
  
  

PRODUCTION/SUPPLIER QUALITY

• Promote the use of Statistical Process Control (SPC), Control Plans and continuous improvement techniques to help them reduce variability, achieve process control, and improve Quality.
• Initiate, track and drive internal Manufacturing and Suppliers Corrective and Preventative Actions (CAPA/SCARs) to ensure complete and effective root cause analysis and corrective action implementation.
• Evaluate and qualify new suppliers and contract manufacturers. Monitor and re-evaluate Approved Suppliers (ASL) assuring continued Supplier conformance to specifications and driving continuous improvement. The evaluations may include Supplier Surveys, Risk Assessments, Supplier Audits, Quality Agreements, Audit Reports, Data Analysis, Material Qualifications, and First Article Inspections.
• Develop positive relationships and effective lines of communication with suppliers, including coaching, driving partnership-oriented arrangements. Directly address supplier issues by setting up conference calls, Combe site meetings and/or visiting supplier sites.
• Help establish and deploy effective Closed-Loop Quality Management Systems that integrates all Quality modules (Audits, Non-conformance tracking, CAPA, Deviations, Change Control, and Training).
• Work closely with the Purchasing Group to establish and maintain Supplier Quality Scorecards (that includes Delivery, Cost, Customer Service, Capability, and Quality).
• Identifies opportunities for reduced inspection of purchased materials based on risk and quality performance.
• Implement Production process controls to mitigate potential on-line failure modes or critical raw material defects.
• Participate as a member of the Material Review Board to review and disposition Supplier and Production related Non-conformances.
• Lead regular meetings to discuss Supplier Quality Topics, including KPIs, Scorecards, Issues, Audit Findings, and OFIs.
  
  

ANALYSIS

• Responsible for gathering and organizing of data for analysis. Make informed decisions based on data.
• Trend and analyze data collected to ensure requirements are met and identify opportunities for improvement.
• Lead or assist with root cause investigations for non-conformances, customer complaints, and CAPAs.
  
  

DOCUMENTATION

• Assist Quality Manager in creating, updating, revising, reviewing and maintaining all Quality/Supplier documentation and Device History Records (DHR’s), including procedures and forms, Quality Agreements, change notification agreements, auto-generated reports, and audit reports.
• Assist in the Quality Systems administration assigned by the Quality Manager.
  
  

PRODUCT DESIGN/DEVELOPMENT

• Participate as a core member of development teams to ensure processes are in place to design and release highly reliable products.
• Manage and maintain Design History Files (DHF).
• Provide Quality Assurance expertise and guidance for New Product Development/Design Control, Risk Management, Manufacturing, Supplier & Material Qualification, and Product Quality.
• Drive and lead design verification and validation activities such as process validation, raw chemical qualification, and first article inspection
• Develop Risk Management Plans and maintain Risk Management Files. Manage and lead Risk Management activities such as dFMEA, pFMEA, uFMEA, Risk Analysis,. Apply Risk Management Process to Supplier Management decisions.
• Assist Manufacturing Engineers and Suppliers in the creation and review of equipment qualifications (IQ/OQ/PQ), drawings/die-lines, sampling plans, process validations, capability studies, and process control implementation.
• Performs all other related job duties as assigned by the Associate Director of Quality
  
  

QUALIFICATIONS AND EDUCATION REQUIREMENTS

• BS in Engineering, Chemistry, Biology, Biotech, Chemical ENG, or other Science related field or equivalent combination of education and experience
• 3 years of experience in a Supplier or Production Quality capacity
• Prefer experience working in a regulated environment with a strong knowledge of medical device (FDA 21 CFR 820/ISO 13485:2016) requirements
• Working knowledge of Quality Systems and Quality related tools, such as FMEA, SPC, Cpk, AQP, DOE
• Prior Supplier and Internal Auditing experience
• Knowledge of 21 CFR 210/211 regulations
• Process validation and IQ/OQ/PQ experience
• AQL/Statistical Sampling experience
• Design Control experience
• Design V&V experience pferred
• ASQ certification, CQE, CSQP and/or CQA or Lead Auditor certification
• Knowledge of ISO 14971
• Practice identifying, mitigating and resolving risks (FMEA, FTA)
• Lean Six Sigma training preferred
• Knowledge of statistical software
• SCAR, CAPA, NCMR and Customer Complaint Investigation and Root Cause Analysis experinece
• Experience with Packaging suppliers and contract manufacturers
• Project Management skills