Quality Manager Job in Wheeling 60090, Illinois US

Excelitas Technologies is a global technology leader with 3,000 employees worldwide and total annual revenue exceeding $300M. At our sites in Wheeling, Illinois, Pfaffenhofen Germany and Shenzhen China, the LED Solutions group develops and manufactures complex LED products for a wide range of applications, including surgical and endoscopic illumination, airfield signaling, hazardous-area lighting, dental lamps, aerospace, and medical therapy.
 

We are currently seeking a Quality Manager for our Wheeling, IL location. The Quality Manager will be responsible for supporting manufacturing process improvements, making a significant contribution to the strategic goal of quality improvement and managing Document Control, IQA and RMA departments. This role will report to the Senior Manager of Global Regulatory Affairs and Compliance. This role will also lead continuous improvement efforts aimed at meeting quality, cost, and on-time delivery while meeting customer expectations and supplier quality management. This role is also responsible for supporting and maintaining the site Quality Management System to meet ISO9001:2008 and ISO 13485:2003 requirements.

 

Responsibilities:

·         Planning and managing product quality, including product qualification and design validation

·         Process analysis and improvement through the implementation of statistical tools and Six Sigma methodology

·         Manage Document Control, IQA and RMA departments and provide guidance to further improve the efficiency of the departments.

·         Act as main customer interface for Quality related matters for the Wheeling site.

·         Manage and oversee the day to day activities of the site Quality Engineers.

·         Lead and or participate in specific production yield improvement projects

·         Participate and contribute in New Product Introduction Process and understand specification development and verification upon transition to production

·         Manage and improve, where applicable, the site Quality system and processes.

·         Work with Quality Engineers and Supply Chain to manage supply quality matters, where applicable.

·         Assist in training the site on ISO 9001:2008, ISO 13485:2003, and ISO 14971:2007

·         Coordinator for the site’s CAPA process including proper closure

·         Support and where applicable conduct internal and external audits

·         Quality performance analysis and reporting

·         Participate in the MRB program

·         Act as Management Representative for the Wheeling site.

Minimum Requirements:

·          Bachelor of Science degree preferred; BS in Electrical, Industrial or Mechanical Engineering preferred with at least eight+ years experience in a manufacturing and/or regulatory environment is preferred.

·          Formal training in statistical techniques in a manufacturing environment with Six Sigma training and certification highly desired.

·          Ability to take responsibility for quality of all products including assembly, testing and yields.

·          Understanding and familiar with design control processes including: design history files, manufacturing process instructions, MRB, failure analysis and corrective/preventive actions and verification testing per cGMP requirements / FDA QSR / ISO 9001/ ISO13485/ ISO 14971 is highly preferred.

·          Knowledge and experience with continuous improvement techniques such as Lean Enterprise, Six Sigma, Kaizen, etc. is desirable.

·          Experience in NPI process management and product quality planning is a big plus

·          Experience working with supplier quality management is desirable.

·          Excellent oral and written communication skills.

·          Proficient in MS Office and MS Project is preferred.

·          ASQ certified Quality Engineer and or ASQ certified Black Belt is beneficial

 

Excelitas offers a comprehensive benefits package including paid time off, health, dental, life, short and long-term disability insurance, paid holidays, tuition reimbursement, and more!

 

This position requires use of information which is subject to the International Traffic in Arms Regulations (ITAR). All applicants must be U.S. persons within the meaning of ITAR. ITAR defines a U.S. person as a U.S. Citizen, U.S. Permanent Resident (i.e. 'Green Card Holder'), Political Asylee, or Refugee.

 

Excelitas is an Equal Employment Opportunity Employer