Engr 2, Quality
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Engr 2, Quality
Ref No.: 18-03410
Location: Vernon Hills, Illinois
Position Type:Contract
Shift:First
Job Category:Engineering
Benefits:401K, Dental Insurance, Life Insurance, Medical Insurance, Vision Insurance
Hiring a Contract Engineer
Duration:  6+ Months
Client Location:  Vernon Hills, IL
Work Schedule:  40 Hours Weekly
Pay Rate:  $30.00 Hourly
Benefits: ACA Compliant Medical Insurance

Responsibilities

The individual works cross-functionally with business unit management, as well as their respective cross-functional teams on matters related to new product design, design transfer, risk management, process/product design, and quality improvement projects & plans. Critical interactions include:
  • 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)
  • Manufacturing and Manufacturing Quality regarding designing for manufacturability, design transfer planning and impact of plant initiated changes
  • Regulatory Affairs and Quality Systems regarding support of regulatory submissions and ensuring new/changing regulations and standards are properly incorporated in quality system procedures.
  • Designated Complaint Handling Unit (DCHU) on addressing post-production data trends, situational analysis, and risk management pre and post production
  • Packaging Technology Center on new/changing product packaging
  • o Sterility Assurance on sterilization process (re)validations, standards and new product design applicability to the proper sterilization cycle and/or modality
  • o Clinical, Marketing, and Sales to define user needs, incorporate VOC, and develop comprehensive design validation
  • o Business Unit Management regarding new product design and development as well as design transfer activities.
  • The major activities of the individual are:
  • o Ensures that all new product development and design change projects meet applicable regulatory (local and international), Corporate, and Unit requirements
  • o Leadership in Design and development planning, design inputs, design outputs, design reviews, design verification, design validation, design transfer, design changes, and design history file maintenance.
  • o Design control excellence: Ensure design control program/process is best-in-class.
  • o Regulatory compliance: Regulatory compliance projects/initiatives, as assigned, in accordance with all applicable regulations (e.g. FDA QSRs (21 CFR Part 820), CMDR, MDD/MDRs, J-PAL), and standards (e.g. ISO 13485 and ISO 14971).
  • o Safety risk management: Champions and drives Lifecycle Risk Management throughout the organization. Assures that appropriate risk management tools are utilized for all programs and projects and that the tools used are consistent with applicable regulatory standards and industry practices.
  • o Supplier management/Supplier audit: Evaluation of new suppliers to support design and development and to drive supplied product/service improvement efforts.
  • o 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.
  • o Inspection/Audit coordination: Assisting the BU and Plant Management Representatives in preparation for third party audits (i.e. FDA inspections, MDSAP audits, notified body audits) and in the effective closure of any findings resulting from such audits.
  • Up to 20% travel may be required.
Education
  • This position requires a bachelor’s degree in Engineering from an accredited four (4) year university.
Required Skills
  • Work under general direction to independently determine and develop solutions.
  • Balance application of technical/engineering principles, quality tools, and regulations/standards.
  • Thrive in a fast paced, improvement oriented business
  • Proven problem solving skills
  • Strong interpersonal skills
  • Excellent verbal & written communication skills
  • Strong computer/software skills
  • Requires a minimum of 2 years Quality Engineering/Design Assurance experience at a medical device manufacturer. Additional experience in the following areas will also be considered: medical device design/manufacturing, validation, safety risk management, regulatory compliance, statistics and sampling methods, and CAPA root cause analysis. Experience with pharmaceutical manufacturing and/or combination product development is a plus.
  • Strong familiarity with regulatory requirements and applicable standards (e.g. 21CFR820, 21CFRPart211, ISO14971, ISO 13485, CMDR, MDD/MDR, and J-PAL), particularly Design Control and Risk Management. ASQ Certification(s) preferred (e.g. Quality Engineering/Auditing)
To Apply for immediate consideration please send resume to Louis Moliterno at Louis.Moliterno@onboardusa.com and reference job # 18-03410 in the Subject Line and indicate the best times to contact you (please include nights and weekends if needed).

**Candidates must complete background and drug screenings before starting any assignment.
 
The On-Board Family of Companies conducts operations through its Corporate Headquarters located in East Windsor, NJ along with Regional Offices in New Castle, DE and Wake Forest, NC.
 
On-Board Services provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics.