Job Description

Title: Supplier Quality Engineer - Intermediate

Location: Lake Forest, IL 60045

Duration: 12 Months

Top 5 skills/requirements - Engineering Degree, Nonconformance Investigation experience, validation experience, ability to troubleshoot quality issues, change control and working with cross functional teams.

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

Experience min.: 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.

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