Sr. Quality Engineer( Design Control,Remediation, DHF) job Round Lake Illinois
Sr. Quality Engineer( Design Control,Remediation, DHF) job Round Lake Illinois
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Sr. Quality Engineer( Design Control,Remediation, DHF) Job

Employer Name: Premier SpiderID: 8874127
Location: Round Lake, Illinois Date Posted: 8/14/2019
Wage: Category: Medical/Health
Job Code:
Number Of Openings: 2

Job Description:
Please submit resumes to rraj at divihn dot com and call (630)  847 0285 with any questions

The Product Quality Engineer applies a solid understanding of theories/practices utilized by other disciplines outside the primary area of expertise toward the development of new or enhanced products. The Quality Engineer will lead from a technical quality perspective to support product development, design change control and verification/validation activities. This position requires a functional understanding of FDA, ISO and the client's Quality systems.

Essential Duties and Responsibilities:
• Ensure compliance with global quality systems and Regulatory requirements related to product and process Design Control, risk analysis, investigations, and CAPAs
• Support the sustainability and life cycle management of an existing product
• Perform design change control activities including impact assessments, reviews, and approvals
• Provide Quality Assurance support and guidance for verification and validation of product requirements
• Support risk management activities as they relate to post market surveillance
• Use statistical trending tools to monitor product complaint trends
• Take lead role in CAPA activities such as investigation, implementation, or verification of effectiveness
• Maintain a high level of expertise in current regulatory requirements
• Perform other duties as assigned

Qualifications for this Role:
• Must have experience or advanced training and demonstrate proficiency in statistical methods
• Completely proficient in relevant products or process development processes
• Good project management skills

Education and Experience
• Bachelors of Science degree in Engineering (discipline: electrical / mechanical / biomedical)
• 4-8 years’ recent relevant experience in the medical device industry.
• Previous experience working with Electromechanical IV pumps or syringe pumps, preferred.
• Demonstrated success in delivering results on technical/product/Quality challenges
• Experience in design control and strong knowledge of DHF and configuration management
• Working knowledge of medical device international standards
• Working knowledge of problem solving and statistical methods as applied to process and product quality preferred
• Product development experience pertaining to electromechanical devices preferred
• Software: Excel (pivot tables, v-lookups)*, Minitab*, Word, PowerPoint, Trackwise 8 (change control / compliant), & TCU

Local candidates are preferred
Interview Platform: phone followed by onsite interviews (30 minutes each individual in)

Job Criteria:
Start Date: 09/09/2019
Position Type: Contractor
Years of Experience Required: 4
Education Required: Bachelors
Overnight Travel:
Vacation Time:

Job Benefits:
Health/Dental Benefits

Contact Information:
Contact Name: Roopa Rajesh Company Type: Recruiter
City: Round Lake
State: Illinois
Zip: 60169
Web Site:

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