Engr 2, Quality

Job Title: Quality Engineer II,

Location: Vernon Hills IL

Duration: 8 Months

Quality Engineering Segment

Department Name: clientI Surgery / Infection Prevention

Reports to: Associate Director, Quality

Prepared by: Associate Director, Quality

Purpose Of Position

The Quality Engineer II is responsible for supporting Design Quality Assurance within the Infection Prevention Platform: Design Controls, Risk Management, Human Factors / Usability Engineering. The incumbent works multi- functionally with teams on new product design, design transfer, risk management, process/product design, quality improvement projects (QIPs) and change to win (CTW) projects.

The incumbent must be able to work under general direction to exercise judgment within generally defined policies and procedures in selecting methods and techniques for obtaining solutions to problems with broad scope and complexity. The incumbent must be able to work closely with business unit and manufacturing plant management as well as other functions (e.g., Regulatory Affairs, Research and Development, Sustaining Engineering, Manufacturing Quality, Operations, Sterility Assurance, Packaging, Sales, Marketing, Finance etc.).

The Individual Collaborates With

• Research and Development and Product Engineering regarding quality planning and project execution that will have significant impact on the business. (i.e., new product design and development, design change, change management)
• Regulatory Affairs and Quality Systems regarding new regulations and standards as they apply to regulatory submissions and managing certain quality procedures.
• Designated Complaint Handling Unit (DCHU) on complaint handling/resolution, situational analysis, and risk management pre-/post- product launch
• Packaging Centers of Excellence on new product packaging projects
• Sterility Assurance on sterilization process (re)validations, standards, and new product design applicability to the proper sterilization cycle and/or modality
• Business Unit Management regarding new product design and development as well as design transfer activities.
  
  

The incumbent reports directly to the Associate Director, Quality for the business unit. The incumbent works cross-functionally with business unit management, as well as their respective teams on matters related to new product design, design transfer, risk management, process/product design, and quality improvement projects and plans.

General Functions, Specific Responsibilities, And Authority

The major activities of the individual are:

• Design Assurance: Quality Planning (i.e., new product development, design assurance, and design transfer). Ensures that all design control and production / process control projects meet applicable regulatory (local and international), Corporate, and Business Unit requirements.
• Design and development planning, design input, design output, design review, design verification, design validation, design transfer, design changes, and design history file maintenance.
• Champions and drives Lifecycle Risk Management throughout the business unit.
• Design risk management: Assure that appropriate risk management tools (i.e., FMEA's) are utilized for all programs and projects and that the tools used are consistent with applicable regulatory standards and industry practices.
• Design control excellence: Continuous monitoring and improvement of the design control program/process to ensure best-in-class processes.
• Change control: Ensure change control projects are comprehensively evaluated and executed per the change control process.
• Regulatory compliance: Regulatory compliance projects/initiatives, as assigned, in accordance with FDA cGMPs (21CFR 210 and 211), QSR's (21 CFR 820), ISO 13485, CMDR, MDD/EU MDR, J-PAL and ISO 14971.
• CAPA: Initiating and directing corrective and preventive actions to problems/issues relating to process and/or product quality, such as complaint resolution, customer interface, and regulatory action.
• Inspection/ Audit coordination: Assisting the BU and Plant Management Representatives in preparation for third party audits (i.e., FDA inspections, notified body audits) and in the effective closure of findings resulting from such audits.
• May provide guidance and work direction to junior Quality Engineers
• The effectiveness of this position can be measured by the health state of Platform Quality Assurance (e.g., successful new product design launches) and critical activities/projects, as assigned, that contribute to the success of the business.
• Up to 15% - 20% travel may be required.
  
  

Knowledge, Education, And Skills Required

Education

This position requires a Bachelor of Science degree in Chemistry or Engineering from an accredited four (4) year university.

Skills

• Work under general supervision to plan, design, and perform as assigned.
• Exercise judgment within generally defined policies and procedures in selecting methods and techniques for obtaining solutions to problems with broad scope and complexity.
• Balance application of technical/engineering principles, quality tools, and regulations/standards.
• Thrive in a fast paced, sometimes ambiguous, improvement-oriented environment
• Proven problem-solving skills
• Strong interpersonal skills
• Excellent verbal & written communication skills Strong computer/software skills
• Basic project management skills
• Results oriented
  
  

Experience

• Bachelor's degree in Engineering or Chemistry from an accredited four (4) year university.
• Minimum 3 years Design Control and Risk Management experience with medical devices.
• Pharmaceutical background and knowledge of combination products, preferred.
• Experience operating in and auditing GMP, GLP.
• Knowledge of statistics and DOE
• Attentiveness to details with strong organizational skills.
• Ability to work proactively and independently.
• Ability to multi-task and efficient in time management.
• Excellent verbal communication and interpersonal skills
• Ability to work in a team environment.
• Proficiency in Excel, Word, and other desktop/general business systems.
  
  

Specialized Knowledge

Strong familiarity with regulatory requirements (FDA 21CFR 210&211, 21CFR 820, ISO 13485, CMDR, MDD/EU MDR, and J-PAL), particularly Design Controls and Risk Management (ISO14971), Statistical software (Minitab) knowledge and Six Sigma Methodology a plus. ASQ Certification(s) (e.g., Quality Engineering/Auditing) a plus.