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The ideal candidate will have a strong background in medical device manufacturing and proven experience supporting New Product Introduction (NPI), risk analysis, PFMEA/FMEA, CAPA, inspection planning, and root cause analysis. This role will work closely with manufacturing, engineering, calibration, and other cross-functional teams, and may also involve direct interaction with customers.
This is a great opportunity for a quality professional who enjoys solving problems, supporting new products, and being a resource to the organization. Key ResponsibilitiesSupport New Product Introduction (NPI) projects from a quality engineering perspective.
Lead and participate in risk analysis, FMEA/PFMEA, and other quality planning activities.
Develop and implement inspection plans and support inspection planning activities.
Lead and support CAPA investigations through root cause analysis, corrective action, and effectiveness activities.
Perform root cause analysis and assist with the resolution of manufacturing and product quality issues.
Partner with manufacturing and engineering teams to identify and implement process and product improvements.
Support calibration teams and related quality activities.
Complete and maintain quality-related data sheets, documentation, and records.
Ensure processes and documentation align with applicable medical device quality requirements, including ISO 13485.Participate in cross-functional project teams and communicate quality requirements, risks, and findings clearly.
Interact with customers as needed regarding quality-related issues and project activities.
Support continuous improvement and help ensure products and processes meet quality and customer requirements.
Required QualificationsBachelor's degree in Engineering, Quality, Manufacturing, or a related technical field.6+ years of Quality Engineering experience in a medical device manufacturing environment.
Strong experience supporting New Product Introduction (NPI).Hands-on experience with FMEA/PFMEA and risk analysis.
Strong CAPA experience, including root cause analysis and corrective action.
Experience developing, implementing, or leading inspection plans.
Strong understanding of medical device quality systems and ISO 13485.Experience working in a manufacturing environment rather than solely in validation or documentation-focused quality roles.
Strong analytical and problem-solving skills.
Ability to work independently and make an immediate contribution with limited training or supervision.
Clear, concise written and verbal communication skills.
Ability to work effectively with cross-functional teams and, when needed, customers.
Preferred QualificationsStrong injection molding experience, particularly in a medical device manufacturing environment.
Experience with manufacturing processes and process improvement.
Experience supporting calibration activities.
Experience working directly with customers on quality-related matters. Qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, or national origin.
SE
Sterling Engineering, Inc.
Quality Engineer
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Job Description
Senior Quality EngineerLocation:
Libertyville, IL Employment Type:
ContractBenefits:
Insurance (Health, Medical, Dental), Paid Holidays, PTO, and More!Schedule:
Full-TimeCompensation:
$50-$60/hr (W2) OverviewWe are seeking an experienced Senior Quality Engineer to support a medical device manufacturing operation in Libertyville, IL. This is an urgent need for a hands-on Quality Engineer who can step in and contribute with minimal training or ramp-up time.The ideal candidate will have a strong background in medical device manufacturing and proven experience supporting New Product Introduction (NPI), risk analysis, PFMEA/FMEA, CAPA, inspection planning, and root cause analysis. This role will work closely with manufacturing, engineering, calibration, and other cross-functional teams, and may also involve direct interaction with customers.
This is a great opportunity for a quality professional who enjoys solving problems, supporting new products, and being a resource to the organization. Key ResponsibilitiesSupport New Product Introduction (NPI) projects from a quality engineering perspective.
Lead and participate in risk analysis, FMEA/PFMEA, and other quality planning activities.
Develop and implement inspection plans and support inspection planning activities.
Lead and support CAPA investigations through root cause analysis, corrective action, and effectiveness activities.
Perform root cause analysis and assist with the resolution of manufacturing and product quality issues.
Partner with manufacturing and engineering teams to identify and implement process and product improvements.
Support calibration teams and related quality activities.
Complete and maintain quality-related data sheets, documentation, and records.
Ensure processes and documentation align with applicable medical device quality requirements, including ISO 13485.Participate in cross-functional project teams and communicate quality requirements, risks, and findings clearly.
Interact with customers as needed regarding quality-related issues and project activities.
Support continuous improvement and help ensure products and processes meet quality and customer requirements.
Required QualificationsBachelor's degree in Engineering, Quality, Manufacturing, or a related technical field.6+ years of Quality Engineering experience in a medical device manufacturing environment.
Strong experience supporting New Product Introduction (NPI).Hands-on experience with FMEA/PFMEA and risk analysis.
Strong CAPA experience, including root cause analysis and corrective action.
Experience developing, implementing, or leading inspection plans.
Strong understanding of medical device quality systems and ISO 13485.Experience working in a manufacturing environment rather than solely in validation or documentation-focused quality roles.
Strong analytical and problem-solving skills.
Ability to work independently and make an immediate contribution with limited training or supervision.
Clear, concise written and verbal communication skills.
Ability to work effectively with cross-functional teams and, when needed, customers.
Preferred QualificationsStrong injection molding experience, particularly in a medical device manufacturing environment.
Experience with manufacturing processes and process improvement.
Experience supporting calibration activities.
Experience working directly with customers on quality-related matters. Qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, or national origin.
Benefits
- Paid Time Off (PTO)
- Health Insurance
- Dental Insurance