Quality Assurance Supervisor

Department / Département: Healthcare
Job Type / Type d'emploi: Full Time
Location / Emplacement: Tempe - AZ

Looking for an opportunity to join a great company whose core purpose is to power the visionaries of this world by delivering them cutting edge infrastructure technology solutions that are tailored to their needs, quickly, reliably and cost efficiently.

As a cutting-edge Montreal-based technology company, Hypertec is a global provider of information technology products and services. Its strategic divisions serve more than 3,000 customers in over 70 countries. Its solutions are employed by organizations from small to large in sectors including cloud providers, media and entertainment, financial services, aerospace, engineering, healthcare, government and education.

To keep up with our rapid growth, we are looking for a Quality Assurance Supervisor to join our growing team, all while being a leading example of our company culture.

CORE RESPONSIBILITIES

  • Maintain the CAPA process and measure its effectiveness;
  • Ensure the role of the management rep for the site;
  • Ensure proper records are kept in relation to QA activities; Participate to the management review and support the corporate QE with the needed inputs;
  • Participate to the management review and support the corporate QE with the needed inputs;
  • Assure that all necessary trainings pertaining to applicable standards and regulations are given for operations staff;
  • Maintain performance metrics and indicators for the performance of the QMS processes.
  • Work collaboratively with operations department to ensure products respect customer and QA expectations;
  • Ensure that all information pertaining to nonconforming products and/or processes is properly recorded and communicated;
  • Report and escalate all nonconformity for the product of processes to the Senior director of operations to ensure immediate action when is needed;
  • Support the customer handling process and leading the RCA meetings;
  • Work with the interested parties to ensure compliance to applicable standards and regulations at all levels (company, county, state, federal; FDA, HIPAA, OSHA);
  • Perform internal audits, report findings, and request corrective actions when applicable;
  • Execute on QA programs in alignment with leadership and organizational priorities.;
  • Based on the performance analysis, take the initiative to ensure the continuous improvement process by respecting the PDCA cycle;
  • Ensure the implementation and the monitoring of the QMS requirements;
  • Monitor and communicate departmental performance on a continuing basis to the corporate director of QE and the Senior Operation director;
  • Participate in regular reviews with the corporate quality department;
  • Support change management processes;
  • Other duties and responsibilities as assigned.

WHAT YOU WILL BRING

  • Bachelor’s degree preferably in engineering or a related discipline with 5+ years of work experience in quality functions;
  • Knowledge of FDA QSR or ISO13485 requirements;
  • Knowledge of the RCA quality tools( 8D,A3,5/7M, etc.);
  • Knowledge of HIPAA and OSHA is an asset;
  • Green belt for Lean & six sigma is an asset;
  • Proficiency in Word, Excel, VISIO and Microsoft Outlook;
  • Strong communication skills English (written & spoken);
  • Strong analytical skills and attention to detail;
  • Recognized for your rigorous approach, your autonomy and your interpersonal skills.

WHAT WE OFFER

  • A dynamic and collaborative work environment;
  • Competitive compensation package;
  • On-site cafeteria;
  • Free access to our 24/7, fully equipped gym + trainer;
  • BBQ, theme days and other employee engagement events;
  • Career advancement opportunities.

Are you up for the challenge? Apply Now

Hypertec is an equal opportunity employer.

Hypertec evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, disability status or any other legally protected characteristic.

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