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QA Supervisor

Company Name: Convaid Products, LLC
Location: Torrance, CA
Job Type: Quality Assurance
Contact Name: Christy Harp
Phone:
Fax: 310-618-8811
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.
Salary: Available upon request

Job Description 

  • Implement, manage, improve and maintain the Environmental & Quality Management System (ISO 13485, ISO 14001, 21 CFR 820, MDD) across the organization
  • Develop and initiate procedures, guidelines and methods for inspection, testing and quality control
  • Actively participate in all internal auditing activities and follow-ups
  • Plan, define and direct the site auditing control program to ensure compliance to all procedures, and policies
  • Ensure quality and compliance of the products manufactured with internal standards and specifications
  • Continuously monitors process performance and action effectiveness, identifying needs and opportunities for improvement
  • Data collection, trending and management of statistical methods
  • Evaluate and supervise regulatory aspects of engineering change orders (ECO)
  • Maintain quality standards for production processes, materials and products
  • Coordinate and manage preventive/corrective actions and continuous improvement initiatives (NCR/CAPA)
  • Motivate and deliver training to the organization on topics related to Quality Management
  • Train, mentor and lead site QA and Production team to insure set goals are met
  • Exert the role of Management Representative and assure, control and report on Quality & Sustainability KPI’s targets
  • Supervise product release, design transfer and review/approve Device Master Record (DMR) and Device History Record (DHR) documentation
  • Conduct process validation and risk management Process Failure Mode and Effects Analysis (PFMEA)
  • Support change management process regarding new products, procedures and standards


Job Requirements

Education: Bachelor degree in engineering, life science or equivalent

Professional experience: At least 5 years of experience in relevant position, direct or indirect experience in the medical device industry will be a strong asset International company work environment experience

Qualifications:
Advanced knowledge of quality systems & working with policies
Quality & Environmental systems implementation skills & experience
Product & process audit skills
Supplier evaluation process skills
Knowledge of analytical and statistical processes
Non-prestigious, social and effective communication skills
Planning and organizing skills
Knowledge and experience in standards and regulatory requirements

IT knowledge:
ERP systems (preferably Movex) & MS Office package knowledge

Personal abilities:
Result oriented
Cooperative team-player who drives results and takes responsibility in influencing others
Flexible and open to new ideas and ways of working
Solution-oriented and structured
Able to communicate efficiently with different stakeholders
Ability to work self-sufficiently in a changing environment
Strong administrative skills