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Senior Quality Manager

Hudson Wisconsin

DESCRIPTION:

The Senior Quality Manager is the leader responsible for all aspects of site quality including quality management system, product quality, customer complaints,  new product introduction, and external quality audits (customer and regulatory) for two Resonetics locations contract manufacturing medical device components.

The Senior Quality Manager is responsible for providing ongoing leadership and direction around its quality management activities, product quality, process controls and equipment that meet customer and regulatory requirements.

The Senior Quality Manager uses Quality Engineering techniques including: Problem solving using Lean Six Sigma methodology, Process Validations, Process Development and optimization, Gage R&R, and reducing dependence on inspection.  The leader is also responsible for ISO compliance.

The Senior Quality Manager works with Resonetics corporate quality to establish and implement quality objectives, best practices­­, procedures, and report on quality metrics.

RESPONSIBILITIES:

  • Liaise with customer quality personnel to resolve issues and Customer Complaints.
  • Hosting customer and regulatory QMS audits
  • Conduct management review.
  • Maintain the QMS as required per Corporate Procedures.
  • Monitor and disseminate customer quality report cards.
  • Oversee and develop validation protocols and reports supporting NPI.
  • Generate Customer Change Notices
  • Assist with troubleshooting of production and PDP processes.
  • Lead development of metrology equipment
  • Develop PFMEA’s
  • Lead corrective action and continuous improvement activities.
  • Resolve Corrective and Preventive Actions in a timely manner.
  • Maintain employee training.
  • Approve nonconforming material disposition.
  • Analyze production and validation data.
  • Working on continual improvement and process assessment projects as assigned.
  • Manage and develop quality engineers, technicians, inspectors, and specialists on site.
  • Ensure corporate procedures are implemented as required.
  • Ensure all regulatory, ISO and customer requirements are maintained as required.

REQUIRED QUALIFICATIONS:

  • Minimum 3 years of experience in a quality leadership role with management responsibility within a medical device manufacturer or contract manufacturer.
  • Minimum 8 years of experience in a Quality role for a medical device manufacturer, contract manufacturer, or equivalent engineering experience.
  • Demonstrated technical writing and communication skills.
  • Working knowledge of statistical software and/or Minitab.
  • Bachelor’s degree or equivalent experience.
  • Prior management experience.
  • Prior experience hosting external quality audits (ISO/customer)

PREFERRED QUALIFICATIONS:

  • CMQOE, CQE and/or Six Sigma Green or Black belt
  • BS degree; Physics, Optics, Mechanical, Chemical, Plastics preferred

PHYSICAL DEMANDS:

Presence at both Resonetics locations required.  Other travel up to 10% may be required.