Quality Manager

  •  

Bridgeport, CT

Industry: Medical Equipment

  •  

8 - 10 years

Posted 249 days ago

  by    Wayne Weeks

This job is no longer available.

ESSENTIAL DUTIES AND KEY RESPONSIBILITIES:

  • Identifies improvements needed and leads project for implementation. Actively participates in safety, health and wellness initiatives.
  • Effectively communicates to all levels of the organization including exempt and non-exempt. Accomplishes this through daily operational meetings, weekly staff meetings, quarterly business reviews, and other mechanisms as determined.
  • Utilizes TQM to define the quality organization and systems. Manage the development and implementation of goals, objectives, policies, procedures and systems. Communicates quality goals, metrics and standards to the organization
  • Identify quality related organization wide training needs and develops programs. Assist in delivering training.
  • Develops customer and final inspection based metrics. Identifies trends and develops action plans.
  • Monitors supplier quality performance and initiates programs to ensure suppliers meet organization and customer expectations.
  • Coordinates customer non-conformance responses.
  • Assists in program launch, machine qualification and equipment validation.
  • Develops, implements, and executes a comprehensive gage control plan.
  • Performs internal audits.
  • Coordinate the improvement of all business systems to maintain TS registration.
  • Assists other business units with associate training, accuracy and improved operation of the MRP system. 
  • Leads Kaizenevents.  
  • Benchmark industry best practices. Develop and implement programs to promote excellence.
  • Ensures compliance with national and international standards and legislation.
  • Supervise quality technical staff to ensure technical excellence. Provides leadership for associate relations through effective communications, coaching, training and development. 
  • Executes plan to enhance profitability, productivity and efficiency throughout the quality department.  

EDUCATION and/or EXPERIENCE

Bachelor's degree in quality assurance or related field or equivalent related experience and a minimum of 7+ years of experience in quality engineering in the medical device industry to include quality system experience to include a quality audits (layered process, document, etc), statistical problem solving, statistical sampling technique, SQC, SPC and higher-level statistical problem solving.   Experience in Materials Science, material specification and tolerancing and raw material processing technique.  Experience with related materials and processes in a high volume precision manufacturing environment. Management and supervisory experiencerequired. ISO 13485 quality system or equivalent experience.     

SKILLS, ABILITIES AND OTHER REQUIREMENTS

  • Proved track record of reducing costs through processes and efficiencies
  • Experience in quality systems. ASQ certification preferred.
  • Demonstrated ability to lead Kaizen events and train Lean Manufacturing techniques.
  • Planning: ability to perform short and long range planning
  • Excellent project and program management skills
  • Ability to apply advanced mathematical concepts and apply statistical control techniques.  
  • Detailed knowledge of principles and practices of mechanicalengineering and design.
  • Demonstrated experience in the use of geometric tolerancing and a full range of measurement technique. 
  • Strong CAD and CMM proficiency
  • Skills in budget preparation and fiscal management

CERTIFICATION/TRAINING REQUIRED

Green Belt certified