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Quality Manager
Quality ManagerGogcm • Leland, NC, US
Quality Manager

Quality Manager

Gogcm • Leland, NC, US
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Overview

Description of the role : Job Description – Quality Manager in the Quality Control department. Reports to : Director of Quality. Summary : The Quality Manager is responsible for the Quality Systems and Inspection at GCM.

Job Responsibilities

  • Develop company strategy to ensure product quality is acceptable with appropriate and demonstrable data
  • ISO9001 : 2008, ISO13485 : 2003 and ITAR certification and compliance
  • Guide company in additional strategic certifications
  • Internal Audit Schedule
  • Coordinate and present Management Review Meetings in accordance with ISO requirements
  • Ensure review and timely action with customer issues, complaints, or rejects
  • Effective and timely communication with all departments with regard to product quality and customer standards
  • Communicate and track Customer Requirements
  • All customer compliance for quality reporting, certifications, and capability analysis
  • All customer audits
  • Document IQ, OQ, PQ for all equipment and "critical processes"
  • Optimization of customer satisfaction through improved operations
  • Target 100% customer lot acceptance and 100% on-time delivery
  • Implementation of productivity and quality metrics to minimize costs and enhance efficiency
  • Effective planning and layout of workflow, equipment, and operations
  • Recruiting, hiring, coaching, and developing staff
  • Job descriptions, goals and objectives, one on one and team communications, etc.
  • Developing and optimizing efficiency of workforce (direct labor as a percentage of sales)
  • Budget and contingency planning
  • Ensures adherence to annual budgets
  • Safety and OSHA compliance in your department
  • Improvement of quality by researching best practices and identifying new technology, skills, and processes
  • 5S, DMAIC process, Kaizen, etc.
  • Support and enhance sales process
  • Recruit, train, supervise, and evaluate department staff
  • Internal Auditor for ISO9001 : 2008. ISO13485 : 2003
  • Must be a team player as measured by his / her peers
  • Performs other related duties assigned

Qualifications and Skills

REQUIRED

  • 10 to 15 years of progressive operational and management experience
  • Relevant industry experience
  • Proven track record in the management of quality assurance
  • DESIRED

  • Bachelor's degree
  • Physical Requirements

    Sitting / Standing / Walking

  • Approximately 50% is spent seated at a desk, working on the telephone or at a computer terminal
  • Approximately 50% is spent bending, squatting, standing, or moving about the work area
  • Frequently lifts, carries, or moves objects weighing up to 25 lbs. and occasionally 50 lbs.
  • Must have ability to use hands to finger, handle, or feel
  • Must have ability to frequently sit, stand, walk, reach within hands and arm's length, stoop, kneel, and crouch
  • Must have ability to sit or stand for extended periods of time
  • Must be able to wear required Personal Protective equipment (PPE) for extended periods of time
  • Must show proficiency in the set-up and operation of all necessary equipment
  • Speaking / Hearing

  • Ability to speak read and write English fluently
  • Clear diction, correct grammar and acute hearing are necessary for effective communication with clients, vendors, management, and other employees
  • Vision

  • Corrected vision close to 20 / 20 is necessary to effectively use computer screens, read reports and respond to correspondence and emails
  • Working conditions are normal for a manufacturing / office environment. Work may require occasional weekend and / or evening work

    Qualifications and Skills (Continued)

    REQUIRED

  • 5 years of experience in Quality Management
  • CAPA, QIP, 5 why and strong problem-solving skills
  • Comfortable with training, employees, co-workers, suppliers in a positive and professional manner
  • Auditing certificate -ISO preferred
  • Supplier experience – management, monitoring, and auditing
  • Travel is required. 3 or more times per year
  • 5 or more years of experience with auditing both internal, customer and external requirements
  • Good knowledge of ISO 13485, ISO 9001 and other relevant specifications
  • Understanding of industry practices and common manufacturing
  • Results orientated, organized, resourceful with high initiative and problem-solving skills, resourceful with high initiative and enjoys working is a fast-paced environment
  • Knowledgeable skills with excel, word, PowerPoint, outlook and Solidworks (is preferred)
  • Experience managing and / or working within a Complaints Management system, per ISO 13485 : 2016 and 21 CFR 820.198
  • Experience investigating, writing, and reviewing deviation and nonconformance reports, CAPA, and Change Requests
  • REQUIRED

  • 10 to 15 years of progressive operational and management experience
  • Relevant industry experience
  • Proven track record in the management of quality assurance
  • Certificate of ISO 13485 or AS9100 Lead Auditor
  • DESIRED

  • Bachelor's degree
  • J-18808-Ljbffr

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    Quality Manager • Leland, NC, US

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