Quality Manager

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Location:
Grand Rapids, MI
Job Type:
Perm

Quality Engineering Manager

Description

Responsible for managing all quality functions related to product and process quality, including quality engineering, metrology, calibration and inspection, supplier product quality, internal non-conformances, process validation, and statistical process control.

 

Main Job Responsibilities

  • Assists in the development and maintenance of the quality systems related to product quality
  • Conducts and coordinates training of all personnel in product quality competencies
  • Interfaces with customers by:
  • Reviewing product quality requirements and specifications
  • Developing quality plans for new products
  • Developing Master Validation Plans for product and process qualification
  • Completing all required phases of product qualification prior to release to production
  • Managing change during life of the products
  • Coordinating validation activities during internal or external product transfers
  • Coordinating investigations, responses, and communication of customer complaints
  • Measures, monitors, and reports on key product quality metrics
  • Drives lean culture and continuous quality improvement through quality policy and quality initiatives
  • Collaborates with functional leaders to support Value Stream teams
  • Participates and supports strategic planning for quality system improvement
  • Develops capital and expense budgets to support business plans
  • Manages, evaluates, and develops product quality personnel
  • Other duties as assigned

 

Knowledge/Education

  • 4-year degree in Engineering or related technical field
  • Knowledge and training in medical quality systems (ISO 13485; 21 CFR 820) is desirable
  • Knowledge and training in compliance inspections, ISO certification and surveillance, and customer audits
  • Strong knowledge in principles, training, and experience in Quality Engineering, such as :
  • Product design and development
  • Quality Engineering (advanced, validation, sustaining, change management)
  • Metrology, GDT, MSA, Calibration
  • Statistics, sampling, and SPC
  • Personnel development and management
  • Lean, six-sigma, and continuous improvement
  • Strong knowledge in quality systems, sub systems and interfacing systems.
  • Complaints, CAPA, Non-Conformances, Audits, Internal Audits, Document Control, Training
  • VQMS (Master Control), QAD, Blue Mountain RAM, Gagetrak, Sharepoint

 

Job Experience

  • Minimum 2 years’ experience in Product Quality or Quality Engineering management
  • Minimum 4 years’ experience in Quality Engineering
  • Experience working in a regulated industry
  • Experience in cleanroom environments preferred

 

Skills/Competencies

  • Strong written and personal communication skills
  • Must be well organized and focused
  • Computer skills required
  • Leadership and Training Knowledge desired

 

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