Confirm your organization ensures the quality policy is understood, implemented and maintained at all levels of your organization through adequate organizational structure to ensure the devices are designed and produced in accordance with the requirements of the Quality System Regulation and ISO 9001.

More Uses of the ISO 9001 Toolkit:

  • Execute lean manufacturing techniques and design using a combination of engineering, project management, structured problem solving and influencing skills.
  • Collaborate with supervisor on the implementation or operation of compliance programs, ensuring organization is aware of any compliance requirements and issues.
  • Perform complex in process and final inspections of an electro mechanical nature using a variety of inspection methods and techniques to determine if a product meets quality standards.
  • Utilize root cause analysis to evaluate all systems for gaps, recommend action and professionally communicate to management the analysis to continually improve quality.
  • Engage in continuous knowledge development regarding sectors rules, regulations, best practices, tools, techniques, and performance standards.
  • Ensure that an internal audit program is adopted to verify that the QMS conforms to planned arrangements and is effectively implemented and maintained.
  • Initiate: strategically plan, develop, promote, and implement programs crafted to improve supplier performance and efficiency and reduce overall costs.
  • Establish that your organization supports engineering efforts by participating in design and process development projects representing quality and ensuring compliance to industry and customer requirements.
  • Steer: equipment qualification, maintenance and calibration research new equipment, methods, and procedures to support ongoing product improvements and new product initiatives.
  • Orchestrate: place physical records into scanner in the right orientation and pressing the right buttons to initiate the scan after the scan is complete (check the quality of the digital copy).
  • Secure that your organization collects and analyzes data for root cause determination and implements continual improvement or problem solving methodologies to improve process performance, quality performance, compliance to requirements, improve customer satisfaction, reduce costs, or improve efficiency.
  • Drive: effectively manage the closed loop problem resolution process to minimize the impact of quality issues to the field/customer from proper material containment and screening to rigorous root cause identification and corrective action implementation to prevent recurrence.
  • Manage project budgets, conduct monthly invoicing, execute project change orders, and seek out invoice collections on multiple concurrent projects.
  • Be accountable for ensuring relevant standard requirements in accordance with ISO 9001, ISO 50001 and other applicable quality/compliance standards in the area of responsibility.
  • Warrant that your organization prioritizes tasks as necessary to assure product and process adherence to applicable specifications/ standards, customer, and internal requirements.
  • Ensure you pilot; build internal relationships, assessing the capabilities of suppliers and service providers, shifting spend to better performing entities and driving continuous improvement.
  • Make decisions regarding accurate application after analyzing remittance detail in comparison with customer open items and organization general ledgers, using established methods and procedures as guidelines for application.
  • Perform finished product evaluations for lot approval, ingredient and packaging evaluations, product development related testing, aql, concerns investigation and effectiveness testing.
  • Maintain engineering compliance to ISO 9001 and ISO 14000 standards and with organization affirmative action plan and organization safety procedures.
  • Audit: under direction, facilitates the development of a quality assurance program and oversees inspections and corrective action plans that meet or exceed maintenance and supply standards.
  • Ensure you account for; lead failure investigation and corrective action for customer related failures, and facilitate customer quality and reliability interactions.
  • Identify: interface with various internal groups (engineering, operations, quality assurance, regulatory, field personnel, marketing) concerning product and customer service issues.
  • Manage the interpretation of in process and analytical data to make quality evaluations, recommend actions for improvement, and assure resolution.
  • Develop high performing team and future leaders by coaching and improving individual capability through performance management systems and processes.
  • Collaborate with human resources department to ensure the implementation of consistent disciplinary action strategies in cases of compliance standard violations.


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