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Quality Control Supervisor

Massachusetts
Job Order: GD-680

Job Descriptions:

  • Manage daily operations of QA department in a machining/Manufacturing environment.
  • Create Validation master plan and execute protocols to support products and process validation for equipment and processes utilized during design verification, validation and manufacturing
  • Develop validation process and procedures to maintain compliance with FDA and customer requirements.
  • Continuously improve existing quality procedure.
  • Plan, develop and execute IQ/OQ/POs for equipment and process utilized during design verification, validation and manufacturing.
  • Assist in the maintenance of ISO 13485-2016 systems, and AS9100D systems. Analyze and recommend appropriate changes to any procedures.
  • Managing quality personnel, including training, evaluation and contribute to hiring and firing decision within the quality department.
  • Oversees usage and maintenance of all quality control equipment and measuring devices. Ensuring all devices are properly utilized and are calibrated and maintained.
  • Work in partnership with manufacturing to ensure proper training and inspection of parts at the machines and establishing proper protocols for in process inspections
  • Working with customers to resolve all returns and product issues in a timely manner-including evaluation on credits, repairs or work charges.
  • Oversight of corrective action system including determining root cause and implementing solution.
  • Assist in development, implementation and maintenance of QA procedural manuals.
  • Manages the inspection department in performing all test and checks while ensuring proper accepted sampling techniques are used and all paperwork is accurate and complete.
  • Operation of SPC System.
  • Development and maintenance of internal audit process.
  • Prepares monthly reports and metrics on all quality areas including performance to goals.
  • Maintains internal document control system
  • Review and approve Customer Certification of Compliance documents
  • Day to day oversight of quality operations and personnel, including movement of material through inspection operations.
  • Establish and maintain timely and appropriate documentation associated with customer and regulatory requirements.
  • Assure document storage and record keeping is appropriate according to the requirements and/or sensitivity of the documents and records.
  • Schedule inspection personnel in support of production schedules. 
  • Evaluate and minimize the impact of creating documentation in support of company policy, customer and regulatory agencies.
  • Completion of all safety and environmental reporting.
  • Support of production as viewed by the Manufacturing Manager.
  • Assuring required, and appropriate, internal controls are established and maintained to safeguard the assets of the Corporation.
  • Management of inspection department resources.

 

Job Requirements:

  • Must possess a background and experience in quality, inspection, and documentation control.
  • Self-starting, detail oriented, person; able to identify the best and least costly alternative for meeting the companies objectives specifically related to quality.
  • Strong interpersonal skills and the ability to manage the performance of her/his subordinates is an additional, vital, qualification requirement. 
  • Should be able to delegate responsibilities and duties, objectively evaluate the performance of others and be able to hold others accountable (in a constructive manner).
  • Clear ability to evaluate cost of quality factors and provide effective direction which minimizes the cost while meeting or exceeding customer expectations.
  • Ability to read and write in English, analyze and interpret common technical journals, blueprints and other technical drawings, and specifications and guidelines from relevant regulatory agencies. 
  • Must have the ability to respond to common inquiries or concerns from others in the organization. 
  • Must be able to communicate well with others, including top management. 

EDUCATION and/or EXPERIENCE:

  • B.S in Business Management, Engineering or equivalent in experience is desirable.
  • Five plus years’ experience with Medical device manufacturing Quality Control.

SKILLS/ Competencies:               

  • Familiarity with manufacturing ERP system and MS office products.
  • Advanced inspection capability & familiar with equipment function, and set-up.
  • Must be able to recommend, prepare and evaluate company quality results
  • Previous responsibility for simplifying documentation requirements and ability to provide efficient support to production.
  • Management and organization of production requirements
  • Cost of quality elements and improvements.

 

DATE POSTED 2019-02-25

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