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Quality Assurance Manager

4 months ago

Sandy, United States Spectrum Plastics Group, A DuPont Business Full time

Job Purpose:

The Quality Assurance Manager ensures compliance to Spectrum Plastics Group (SPG) Core Values, Customers, Teammates, Future, while fulfilling the needs of the industry and community. They will direct Sandy's Quality department and provide a structured system that requires delivered part quality meets or exceeds customer expectations; ensures compliance to and maintenance of ISO 13485 Quality standard certification; and promotes awareness of customer requirements throughout the facility.


Essential Duties and Responsibilities:

  • Act as a Sandy Management Representative for all Quality Systems matters.
  • Has the independent authority, responsibility and access to top management to resolve quality management issues
  • Organize, chair, document, and distribute QMS Management Review meetings
  • Manage and direct internal audits of quality system and report on Quality System performance to top management
  • Establish and maintain Sandy's Quality Management System and comply to SPG corporate Quality policies
  • Provide the management team and others with regular reports against quality objectives.
  • Direct quality control objectives and ensure that products produced meet required standards
  • Oversee and ensure calibration, testing, source inspection, in-process inspection, and final inspection of product
  • Direct in-plant control of non-conforming product, including quarantine of product not meeting quality requirements
  • Oversee internal and external corrective and preventive action (CAPA) processes and ensure that corrective actions are completed in a timely manner
  • Lead Continuous Improvement projects including Lean, Six Sigma activities, Scrap reduction, FPY improvement etc.
  • Lead automation projects like new metrology improvements, electronic QMS, SPC etc.
  • Respond to customer complaints and resolve issues in a prompt and professional manner
  • Coordinate with departmental managers to ensure appropriate, required and accurate collection, retention, storage, and control of quality system documents and records
  • Participate in new product development and R&D activities. Active responsibility in APQP process to review and provide input to new part feasibility
  • Ensure that first article inspection, PPAP and other pre-production qualifications are per customer requirements
  • Perform other accountabilities as assigned


Responsibility for Work of Others:

  • Direct supervisory responsibility over Quality direct reports
  • Direct temporary employees and other department employees assigned to quality related assignments
  • Work closely with other department managers, supervisors and employees to ensure adherence to customer and quality policy manual requirements


QUALIFICATIONS (Education/Experience/Knowledge, Skills & Abilities)

Required:

  • Bachelor’s degree in a technical discipline or relevant medical device Quality Management, Quality Engineering or Quality Systems experience
  • 5 + years of experience in Quality Engineering function preferably in Medical Device Manufacturing
  • 3 to 5 years Quality Management experience in a regulated manufacturing environment preferred
  • Experience managing a large team with multiple shifts
  • Excellent English communication skills, both written and verbal
  • Strong management and supervisory skills with a focus on teamwork
  • Training and experience in ISO 9001, ISO 13485 and/or FDA regulated quality systems requirements
  • Training and experience in formal Root Cause problem-solving techniques (8D, 5 why etc.) and lean manufacturing.


Physical Demands

  • Regularly required to sit, stand, walk, and move about the facility
  • Occasionally required to bend and stoop.


Work Environment

  • Works in an office and manufacturing environment
  • While performing the duties of this job, the employee is occasionally exposed to fumes or airborne particles and noise associated with the extrusion and fabrication manufacturing processes