Quality Assurance Engineer (PPG#333768) - Barton Staffing Solutions
St. Charles, IL 60185
About the Job
Our Client, a leading contract manufacture of superior medical devices is seeking an experienced 1st Shift Quality Assurance Engineer for their facility located in St. Charles, IL
This is a Direct Hire position that ensures that the quality related engineering needs of the organization are met. Responsibilities include compliance and risk analysis, process validation, pFEMA’s, IQ, OQ, PQ and PPQ validation. Position works in collaboration with operations, supply chain, & new product development teams.
Essential Functions:
- Lead in supporting compliance for medical device manufacturer in ID/Traceability throughout supply chain, well documented and executed Acceptance Activities, Non-conforming material management, Packaging/Labeling control, Production/Process controls, and Process Validation.
- Risk Assessments, project meetings, pilot builds, First Article Inspections, and Post Market Risk Management.
- Designs and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and/or production equipment.
- Design and execution of pFEMA’s, IQ, OQ, PQ and PPQ validation.
- Corrective and Preventive Action management, facilitation, ownership, and problem resolution.
- Process improvement and support, including Quality System process review and revision.
- Training assistance, including providing training in quality system activities/requirements.
- Internal and external audit coordination and facilitation.
Compensation range: $75,000-$95,000/yr
Company offers excellent benefit package, friendly work environment.
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Requirements:
• A Bachelor's degree in science, engineering or equivalent
• 10 or more year’s relevant experience
• At least 5 years’ experience in medical device manufacturing is required.
• Strong knowledge of Quality Systems policies and regulations (ISO 13485 and FDA Part 820) with a strong background in medical device quality assurance and processes is required.
• Experience conducting supplier audits and writing supplier contracts.
• Familiarity with statistical analysis.
Apply NOW by Clicking on "Apply Now"
Or Send your resume to Apply@BartonPPG.com
Or Apply online at www.Bartonstaffing.com
Or Send your resume to Apply@BartonPPG.com
Or Apply online at www.Bartonstaffing.com
Requirements:
• A Bachelor's degree in science, engineering or equivalent
• 10 or more year’s relevant experience
• At least 5 years’ experience in medical device manufacturing is required.
• Strong knowledge of Quality Systems policies and regulations (ISO 13485 and FDA Part 820) with a strong background in medical device quality assurance and processes is required.
• Experience conducting supplier audits and writing supplier contracts.
• Familiarity with statistical analysis.
Apply NOW by Clicking on "Apply Now"
Or Send your resume to Apply@BartonPPG.com
Or Apply online at www.Bartonstaffing.com
Or Send your resume to Apply@BartonPPG.com
Or Apply online at www.Bartonstaffing.com
Source : Barton Staffing Solutions
