Combe Incorporated
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Base pay range
$65,000.00/yr - $70,000.00/yr This is a full-time position ON-SITE in Rantoul, IL - not hybrid or remote The Quality Engineer (QE) 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 QE tracks data, identifies improvement projects, and manages cross functional implementation to improve performance in Production and Supplier Quality. The QE has high upstream focus to limit cost and time investment maximizing Product Quality.
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.
Read, understand and follow Quality Management Systems documentation for each function performed.
Work 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 work to improve processes in the company and its relationship to the community.
Production / Supplier Quality
Promote the use of SPC, Control Plans and continuous improvement techniques to reduce variability, achieve process control, and improve quality.
Initiate, track and drive internal Manufacturing and Suppliers CAPA/SCARs for root cause analysis and corrective action implementation.
Evaluate and qualify new suppliers and contract manufacturers; monitor approved suppliers ensuring conformance and driving continuous improvement. Activities may include surveys, risk assessments, audits, quality agreements, reports, data analysis, material qualifications, and first article inspections.
Develop relationships and communication with suppliers, coaching and partnership-oriented arrangements; address supplier issues via calls, site meetings or visits.
Establish and deploy Closed-Loop Quality Management Systems integrating audits, non-conformance tracking, CAPA, deviations, change control, and training.
Work with Purchasing to maintain Supplier Quality Scorecards (delivery, cost, service, capability, quality).
Identify opportunities to reduce 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 in the Material Review Board to review and disposition supplier and production non-conformances.
Lead regular meetings on supplier quality topics, KPIs, scorecards, issues, audit findings, and opportunities for improvement.
Analysis
Gather and organize data for analysis; make informed decisions based on data.
Trend and analyze data to ensure requirements are met and identify improvement opportunities.
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 Quality/Supplier documentation and Device History Records (DHRs), including procedures, forms, Quality Agreements, change notifications, reports, and audit documents.
Assist in Quality Systems administration as 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 for New Product Development / Design Control, Risk Management, Manufacturing, Supplier & Material Qualification, and Product Quality.
Lead design verification and validation activities such as process validation, raw material qualification, and first article inspection.
Develop Risk Management Plans and maintain Risk Management Files; lead risk management activities (dFMEA, pFMEA, uFMEA, risk analysis).
Apply Risk Management processes to supplier management decisions.
Assist Manufacturing Engineers and Suppliers in equipment qualifications, drawings, sampling plans, process validations, capability studies, and process control implementation.
Performs other related duties as assigned by the Associate Director of Quality.
Qualifications and Education Requirements
BS in Engineering, Chemistry, Biology, Biotech, Chemical Engineering or related field, or equivalent combination of education and experience
3+ years of experience in a Supplier or Production Quality Engineering role
Experience in a regulated environment with knowledge of medical device (FDA 21 CFR 820/ISO 13485:2016) requirements
Working knowledge of Quality Systems and 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 and Design V&V experience
ASQ certification (CQE, CSQP, CQA) or Lead Auditor
Knowledge of ISO 14971
Experience identifying, mitigating and resolving risks (FMEA, FTA)
Lean Six Sigma training preferred
Knowledge of statistical software
Experience with SCAR, CAPA, NCMR and Customer Complaint investigations
Experience with packaging suppliers and contract manufacturers
Project management skills
Job details
Seniority level: Mid-Senior level
Employment type: Full-time
Job function: Quality Assurance
Industries: Consumer Goods
Champaign, IL – Referrals and related postings are noted for context but should not be considered part of this specific job description.
We’re not providing further job postings here. Get notified about new Quality System Engineer jobs in Rantoul, IL.
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$65,000.00/yr - $70,000.00/yr This is a full-time position ON-SITE in Rantoul, IL - not hybrid or remote The Quality Engineer (QE) 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 QE tracks data, identifies improvement projects, and manages cross functional implementation to improve performance in Production and Supplier Quality. The QE has high upstream focus to limit cost and time investment maximizing Product Quality.
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.
Read, understand and follow Quality Management Systems documentation for each function performed.
Work 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 work to improve processes in the company and its relationship to the community.
Production / Supplier Quality
Promote the use of SPC, Control Plans and continuous improvement techniques to reduce variability, achieve process control, and improve quality.
Initiate, track and drive internal Manufacturing and Suppliers CAPA/SCARs for root cause analysis and corrective action implementation.
Evaluate and qualify new suppliers and contract manufacturers; monitor approved suppliers ensuring conformance and driving continuous improvement. Activities may include surveys, risk assessments, audits, quality agreements, reports, data analysis, material qualifications, and first article inspections.
Develop relationships and communication with suppliers, coaching and partnership-oriented arrangements; address supplier issues via calls, site meetings or visits.
Establish and deploy Closed-Loop Quality Management Systems integrating audits, non-conformance tracking, CAPA, deviations, change control, and training.
Work with Purchasing to maintain Supplier Quality Scorecards (delivery, cost, service, capability, quality).
Identify opportunities to reduce 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 in the Material Review Board to review and disposition supplier and production non-conformances.
Lead regular meetings on supplier quality topics, KPIs, scorecards, issues, audit findings, and opportunities for improvement.
Analysis
Gather and organize data for analysis; make informed decisions based on data.
Trend and analyze data to ensure requirements are met and identify improvement opportunities.
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 Quality/Supplier documentation and Device History Records (DHRs), including procedures, forms, Quality Agreements, change notifications, reports, and audit documents.
Assist in Quality Systems administration as 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 for New Product Development / Design Control, Risk Management, Manufacturing, Supplier & Material Qualification, and Product Quality.
Lead design verification and validation activities such as process validation, raw material qualification, and first article inspection.
Develop Risk Management Plans and maintain Risk Management Files; lead risk management activities (dFMEA, pFMEA, uFMEA, risk analysis).
Apply Risk Management processes to supplier management decisions.
Assist Manufacturing Engineers and Suppliers in equipment qualifications, drawings, sampling plans, process validations, capability studies, and process control implementation.
Performs other related duties as assigned by the Associate Director of Quality.
Qualifications and Education Requirements
BS in Engineering, Chemistry, Biology, Biotech, Chemical Engineering or related field, or equivalent combination of education and experience
3+ years of experience in a Supplier or Production Quality Engineering role
Experience in a regulated environment with knowledge of medical device (FDA 21 CFR 820/ISO 13485:2016) requirements
Working knowledge of Quality Systems and 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 and Design V&V experience
ASQ certification (CQE, CSQP, CQA) or Lead Auditor
Knowledge of ISO 14971
Experience identifying, mitigating and resolving risks (FMEA, FTA)
Lean Six Sigma training preferred
Knowledge of statistical software
Experience with SCAR, CAPA, NCMR and Customer Complaint investigations
Experience with packaging suppliers and contract manufacturers
Project management skills
Job details
Seniority level: Mid-Senior level
Employment type: Full-time
Job function: Quality Assurance
Industries: Consumer Goods
Champaign, IL – Referrals and related postings are noted for context but should not be considered part of this specific job description.
We’re not providing further job postings here. Get notified about new Quality System Engineer jobs in Rantoul, IL.
#J-18808-Ljbffr