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Quality Manager

Quality Manager

SIM SurgicalFenton, MO, US
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Overview

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The Quality Manager is responsible for overseeing all aspects of quality, ensuring product integrity and compliance with company standards, industry regulations, and customer requirements. This role involves leading a team of quality professionals, maintaining a quality management system, and driving continuous improvement.

Responsibilities

  • Be a role model for the company culture.
  • Develop, implement, and management systems designed to ensure continuous production of products consistent with established standards, customer specifications, and production goals.
  • Supervise and oversee the adaptation of new quality processes, standards, and specifications.
  • Lead, manage, and develop the quality assurance team to achieve quality objectives.
  • Provide coaching and training to quality assurance personnel on systems, policies, procedures, and core processes.
  • Ensure compliance with national and international standards and legislation.
  • Plan, conduct, and monitor testing and inspection of materials and products to ensure finished product quality.
  • Coordinate and support on-site audits conducted by external providers or regulatory inspectors.
  • Serve as Management Representative for ISO 13845 : 2016
  • Analyze data to identify areas for improvement in the quality system.
  • Develop, recommend, and monitor corrective and preventive actions.
  • Prepare reports to communicate outcomes of quality activities to management.
  • Interface with customers to understand their quality requirements and resolve quality issues.
  • Ensure a high level of internal and external customer service by investigating and acting on customer complaints regarding quality.
  • Promote quality achievement and performance improvement across the organization.
  • Lead the team in identifying, planning, and implementing key projects to improve quality, reduce costs, and increase productivity.
  • Perform tasks as required to help meet needs of business.

Requirements

  • Bachelor's degree in science, engineering or technical field, or equivalent experience.
  • Minimum of 5 years of experience in quality assurance, quality control, or a related field, including at least 2 years in a managerial role.
  • Working knowledge of FDA medical device regulations, guidance documents, international standards
  • Excellent communication skills, both verbal and written.
  • Proficient in the use of MS Office and quality management software.
  • Leadership and people management skills.
  • Strong problem-solving and analytical skills.
  • Detail-oriented with a methodical approach to work.
  • Ability to manage multiple projects simultaneously and under tight deadlines.
  • Strong organizational and follow-up skills.
  • Physical Requirements

  • Regularly required to sit, stand, walk, climb, stoop and crouch, reach, grasp, feel, talk, and hear.
  • Must be able to move around large areas.
  • Must be able to lift, carry, or otherwise move objects unassisted.
  • Required to lift more than 25 pounds occasionally and / or up to 50 pounds rarely.
  • Required to see clearly at a distance of 20 inches or less.
  • Must be able to judge distance and spatial relationships.
  • Must be able to visually bring objects into sharp focus for reading machine dial gauges, blueprints, and precision measuring instruments used in the inspection of parts.
  • This role may require occasional travel.
  • Physical requirements include the ability to work in an office setting and visit production areas.

    Seniorit y level

  • Mid-Senior level
  • Employment type

  • Full-time
  • Job function

  • Information Technology
  • Industries
  • Wireless Services, Telecommunications, and Communications Equipment Manufacturing
  • Referrals increase your chances of interviewing at SIM Surgical by 2x

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