Quality Engineering Lead

Company: Nemera La Verpilliere
Location: Buffalo Grove
Posted on: January 26, 2023

Job Description:

• 600 Deerfield Parkway, Buffalo Grove, IL, 60089, US Posting Date 09/01/2022, 04:48PM Degree Level Bachelor's Degree Job Schedule Full time Job Description Overview: The Quality Engineering Lead is "hands-on" position responsible for planning, coordinating and managing through completion, assigned projects to ensure the development and production of products meets customer and internal quality deliverables. Responsibilities:
  • Assists the Plant Quality Manager in coordinating and executing objectives throughout the company in cooperation with other managers, to maximize product quality and operating system efficiency/effectiveness while minimizing cost.
  • Responsible for qualification of mold, processes from quality and compliance standpoint
  • Maintain documentation related to new asset delivery at Nemera
  • Create Validation Protocols and Reports, Product Specifications, and Change Control activities including assessment for compliance with internal procedures and regulatory requirements
  • Coordinate and manage the execution of validations protocols and change control requests.
  • Assess results of Customer Complaint investigations and Corrective Actions for application, validity and conformance to FDA regulatory, QSR, ISO and Customer requirements.
  • Develop and analyze statistical data in relationship to assigned tasks to determine adequacy of present standards and establish proposed quality improvements, including analysis of current inspection methods and sample plans.
  • Develop product specifications for existing products and assess existing specifications for accuracy and compliance.
  • Plan, promote, perform and organize training activities for internal departments related to quality activities, including basic statistics, DOE, GR&R and Sample Plan designation.
  • Interact with customers to assure mutual interpretation of specified requirements to ensure fulfillment of customer requirements and objectives are met.
  • Assist in maintaining ISO and FDA QSR quality systems compliance.
  • Execute specific responsibilities as defined within the company quality operating system.
  • Support and maintain all policies of the company, including but not limited to applicable FDA regulatory and ISO requirements, Health and Safety Requirements and Continuous Improvement initiatives.
  • Identify and complete continuous improvement projects utilizing Six Sigma tools and methodologies.
  • Other duties as assigned. Preferred/Required Education/Skills:
    • Bachelor's degree in Engineering, Science or related field.
    • 5 or more years of experience in a Quality position within Medical Device industry required. At least 2 years at lead or supervisor role
    • Technical writing experience preferred
    • Experience in the Medical Device industry preferred.
    • Must be self-directed and possess knowledge of business and management principles involved in strategic planning, resource allocation and coordination of people and resources
    • Excellent communication skills with the ability to understand, read, write and speak English required.
    • Must have the ability to apply advanced mathematical concepts and intermediate statistical (SPC) knowledge.
    • Six-sigma experience, training or certification preferred.
    • Intermediate level computer skills, including Microsoft Office applications required
    • SAP experience preferred.
    • Ability to work independently from verbal and/or written instructions required.
    • Works in a clean manufacturing environment that may include moderate noise levels and required appropriate PPE and cleanroom apparel.
    • Ability to regularly lift up to 30 lbs with repetitive movements.
    • Ability to push and pull items.
    • Ability to stand, sit, walk up to 80% of a shift.
    • Ability to travel between office and production departments as well as company buildings required.
    • Up to 25% travel required (some international). The Quality Engineer is responsible for planning, coordinating and managing through completion, assigned projects to ensure the development and production of products meets customer and internal quality deliverables. Coordinate and lead investigations regarding customer complaints. Work with Supply Chain management to evaluate and manage supplier performance. Duties and responsibilities are accomplished personally or through collaboration with other staff. Provide guidance, direction, and coordination of work to the Quality Control staff to ensure continuous production and distribution of products consistent with established standards. Address quality issues and concerns during production and sample runs; distribute or assign work as needed. Evaluate compliance using relevant information and individual judgment to determine whether events or processes comply with specifications, operating procedures or standards. Duties and responsibilities are accomplished personally or with other Quality Control staff. Indirectly responsible for the work outcomes and productivity of the QC staff.

Keywords: Nemera La Verpilliere, Buffalo Grove , Quality Engineering Lead, Professions , Buffalo Grove, Illinois