Quality Engineering Lead
Company: Nemera La Verpilliere
Location: Buffalo Grove
Posted on: January 26, 2023
- 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
- Create Validation Protocols and Reports, Product
Specifications, and Change Control activities including assessment
for compliance with internal procedures and regulatory
- 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
- 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
- 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
- 5 or more years of experience in a Quality position within
Medical Device industry required. At least 2 years at lead or
- 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
- SAP experience preferred.
- Ability to work independently from verbal and/or written
- Works in a clean manufacturing environment that may include
moderate noise levels and required appropriate PPE and cleanroom
- Ability to regularly lift up to 30 lbs with repetitive
- 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
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