Supplier Quality Engineer Intermediate

We have Contract role Supplier Quality Engineer Intermediate for our client at Lake Forest, IL. Please let me know if you or any of your friends would be interested in this position.

Position Details: Supplier Quality Engineer Intermediate- Lake Forest, IL Location : Lake Forest, IL - 60045 Project Duration : 12+ months of contract
Pay range : $45-$48 an hour on W2

Main Purpose of Role:

• Conduct quality-related activities to deliver consistent high quality documents; services; products and processes.
• Supporting supplier quality activities for injection molding (plastic) part used in manufacturing of Reagent Kits.

Main Responsibilities:

• Responsible for implementing and maintaining the effectiveness of the quality system.
• General
• Defines project goals and milestones.

• Responsible for timely project completion.
• Provides solutions to a wide range of difficult problems.
• Ensures that solutions are compliant; innovative; thorough; practical and consistent with organizational objectives.
• May lead projects with cross-functional or broader scope.
• Interacts effectively with employees; manager; and cross-functional peers.
• May represent own team while on cross-functional project teams with other functional leaders.
• Communicates confidently and effectively with management; peers; and key stakeholders.
• Implements tactical solutions related to assignment.
• Able to contribute functional skills and expertise broadly.
• Directly influences project direction and scope.
• Scope includes one or more QA functions; with general knowledge of other related disciplines.
• Provides guidance and trains other Professionals and Technicians.
• May provide oversight to one or more QA professionals and/or contractors.
• Quality System Compliance Demonstrates good; general understanding of the standards and regulatory bodies that regulate our industry.
• Ensures compliance to site level policies and procedures and demonstrates a solid understanding of Division and Corporate policies and procedures by promptly addressing noncompliance issues within Division and Corporation as appropriate.
• Ensures adherence and maintains the effectiveness of the Quality System; including the Subsystems and Key processes that govern the area by promptly addressing noncompliance issues.
• Risk Management
• Ensures evaluation of product safety and efficacy and elevation of risk-based issues.
• Creates and reviews risk management documentation to reduce or eliminate risk.
• Makes independent decisions within defined parameters while assuring that these decisions are compliant with site level policies and procedures and are aligned with the appropriate quality system.
• Authors risk control packages and demonstrates the ability to analyze; evaluate; and control risk decisions by utilizing common practices throughout the quality
• Complaint Evaluation
• Investigates complex complaints with little management oversight.
• Provides solutions to a wide range of problems.
• Solutions are compliant; innovative; thorough; practical and consistent with organizational objectives.
• Ensures compliant documentation in area of responsibility.
• Design Control / Documentation & Change Control
• Formulates thorough reason and justification for change.
• Identifies critical parameters associated with change.
• Represents the site as an SME or Process Community member.
• Quality Engineering
• Applies solid understanding of quality system elements from product inception through launch.
• While recognizing project interdependencies and with minimal oversight; leads complex quality discussions across various departments including; as needed; external suppliers.
• Validation
• Acts as Subject Matter Expert (SME) for minimum of at least one respective Validation Subsystem.
• Receives general direction and exercises considerable discretion to own work detail.
• Recommends possible solutions.
• Ensures compliant documentation; carrying out tasks related to area of responsibility with management oversight.
• Decisions may have short and long-term impact.

Education:

• Bachelors Degree In Life Science, Engineering, or closely related discipline.

Experiences:

• Preferred experience in the Healthcare industry. Has a history of completing successful projects and driving positive compliance outcomes.
• Minimum 8-10 years In Quality or related field experience; Less experience may be appropriate with advanced degree. Manager would like to see experience in medical device/pharm industry.

Top five skills/requirements

• Engineering Degree
• Nonconformance Investigation experience
• validation experience
• ability to troubleshoot quality issues
• Change control and working with cross functional teams.