<img src="https://www.getinge.com/siteassets/start/company/careers/Global_careers-portal90127.jpg" alt=""> With a passion for life Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers. Are you looking for an inspiring career? You just found it. With a passion for life Rejoignez nos équipes diversifiées de personnes passionnées et une carrière qui vous permet de vous développer au niveau personnel et professionnel. Chez Getinge, nous existons pour rendre les technologies qui sauvent des vies accessibles à un plus grand nombre de personnes. Pour faire une vraie différence pour nos clients – et pour sauver plus de vies, nous avons besoin de team players, forward thinkers, et game changers. Cherchez-vous une carrière inspirante? Vous venez de la trouver. In our Quality/Regulatory Department we are looking for ... A Quality Manager Job Overview The main function of the Quality Manager is to maintain all aspects of the established Canadian SSU’s Quality Management System in compliance to the applicable ISO standards. They will liaison between the global and local organization to ensure best practices are established and enforced. The Quality Manager will also conduct internal audits, represent the company in third party audits and provide feedback on process improvements. This position maintains and leads all Canadian SSU CAPAs. Job Responsibilities and Essential Duties <ul> <li style="margin:0.0in 0.0in 1.0 E-4pt 0.0px;font-size:12.0pt;font-family:Arial, sans-serif">Maintains the implementations of the corporate Quality Management System per ISO 9001 and ISO 13485 standards. </li> <li style="margin:0.0in 0.0in 1.0 E-4pt 0.0px;font-size:12.0pt;font-family:Arial, sans-serif">Identify and assess Quality System risks for assigned projects or programs.</li> <li style="margin:0.0in 0.0in 1.0 E-4pt 0.0px;font-size:12.0pt;font-family:Arial, sans-serif">Maintains required QMS records.</li> <li style="margin:0.0in 0.0in 1.0 E-4pt 0.0px;font-size:12.0pt;font-family:Arial, sans-serif">Create, or assist in the creation of, Standard Operating Procedures to maintain practical, efficient compliance to Getinge’s GetQMS and Global Sales’ Quality Systems requirements.</li> <li style="margin:0.0in 0.0in 1.0 E-4pt 0.0px;font-size:12.0pt;font-family:Arial, sans-serif">Represents Getinge to outside parties and supports all third party quality systems inspections and audits.</li> <li style="margin:0.0in 0.0in 1.0 E-4pt 0.0px;font-size:12.0pt;font-family:Arial, sans-serif">Performs Internal Audit activities in line with applicable standards.</li> <li style="margin:0.0in 0.0in 1.0 E-4pt 0.0px;font-size:12.0pt;font-family:Arial, sans-serif">Maintain applicable KPI’s and reports to management.</li> <li style="margin:0.0in 0.0in 1.0 E-4pt 0.0px;font-size:12.0pt;font-family:Arial, sans-serif">Performs all corrective and preventative actions and maintains documentation.</li> <li style="margin:0.0in 0.0in 1.0 E-4pt 0.0px;font-size:12.0pt;font-family:Arial, sans-serif">Act as Subject Matter Expert on Quality System processes internally and externally.</li> <li style="font-size:12.0pt;font-family:Arial, sans-serif">Acts as a key driver of change within the organization, supporting peers and leaders by implementing and communicating training requirements and educating team members on how training is a key part of compliance initiatives.</li> <li style="font-size:12.0pt;font-family:Arial, sans-serif">Conduct New Hire Quality System Training and other trainings as needed. </li> <li style="margin:0.0in 0.0in 1.0 E-4pt 0.0px;font-size:12.0pt;font-family:Arial, sans-serif">Prepares and facilitates Management Review meetings including all required inputs and follow up action items.</li> <li style="margin:0.0in 0.0in 1.0 E-4pt 0.0px;font-size:12.0pt;font-family:Arial, sans-serif">Strengthen Quality Management System awareness, support Sales & Service teams, and process improvements. </li> <li style="margin:0.0in 0.0in 1.0 E-4pt 0.0px;font-size:12.0pt;font-family:Arial, sans-serif">Maintains current knowledge base of all QMS related changes within the industry.</li> <li>Performs other related duties as required or assigned</li> </ul> This position will be hybrid. Our office is located in Mississauga, Ontario. Minimum Requirements <ul style="margin-top:0.0in;margin-bottom:0.0in"> <li style="margin:0.0in 0.0in 1.0 E-4pt 0.0px;font-size:12.0pt;font-family:Arial, sans-serif">Bachelor’s degree or equivalent education. </li> <li style="margin:0.0in 0.0in 1.0 E-4pt 0.0px;font-size:12.0pt;font-family:Arial, sans-serif">A minimum of seven (7) or more years of experience in quality assurance, quality control or related functions in a FDA/Health Canada regulated industry or ISO certified organization is required. Seven to ten years of related experience managing and implementing Quality Management systems in the medical device or pharmaceutical or related industry is preferred.</li> </ul> Required Knowledge, Skills and Abilities <ul style="margin-top:0.0in;margin-bottom:0.0in"> <li style="margin:0.0in 0.0in 1.0 E-4pt 0.0px;font-size:12.0pt;font-family:Arial, sans-serif">Demonstrated expertise with quality agreements, negotiations, and metrics/trending analysis. </li> <li style="margin:0.0in 0.0in 1.0 E-4pt 0.0px;font-size:12.0pt;font-family:Arial, sans-serif">Knowledge and experience in the application of a Quality Management System and all associated requirements.</li> <li style="margin:0.0in 0.0in 1.0 E-4pt 0.0px;font-size:12.0pt;font-family:Arial, sans-serif">Excellent communication and interpersonal skills (oral and written).</li> <li style="margin:0.0in 0.0in 1.0 E-4pt 0.0px;font-size:12.0pt;font-family:Arial, sans-serif">Must have demonstrated presentation, facilitation skills and the ability to interact and communicate with senior management and Sales/Service/Field staff at all levels. </li> <li style="margin:0.0in 0.0in 1.0 E-4pt 0.0px;font-size:12.0pt;font-family:Arial, sans-serif">Must be able to facilitate teams to drive in the use of critical thinking, problem solving and decisions.</li> <li style="margin:0.0in 0.0in 1.0 E-4pt 0.0px;font-size:12.0pt;font-family:Arial, sans-serif">Must have effective problem-solving, decision making, influencing and negotiation skills as well as the ability to assess the impact of Quality System strategies on business performance.</li> <li style="margin:0.0in 0.0in 1.0 E-4pt 0.0px;font-size:12.0pt;font-family:Arial, sans-serif">Must have in-depth knowledge of all applicable Quality System Standards. Targeted salary range $97,900.00 - $115,000.00 + 15% bonus #LI-JF1 #LI-Hybrid </li> </ul> About us With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries. Benefits at Getinge: At Getinge, we offer a comprehensive benefits package, which includes: <ul> <li>Health, Dental, Vision and Travel insurance benefits</li> <li>Registered Pension Plan with company match</li> <li>Paid Time Off</li> <li>Wellness initiative & Health Assistance Resources</li> <li>Life Insurance</li> <li>Short and Long Term Disability Benefits</li> <li>Hybrid Work Arrangements (where applicable)</li> <li>Parental and Caregiver Leave</li> <li>Tuition Reimbursement</li> </ul> Getinge is an equal opportunity employer. Getinge will, at all times, will comply with all applicable human rights and other legislation when considering all qualified applicants for employment. Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process. À propos de nous Avec la ferme conviction que chaque personne et chaque communauté doit avoir accès aux meilleurs soins possibles, Getinge fournit aux hôpitaux et aux institutions des sciences de la vie des produits et des solutions visant à améliorer les résultats cliniques et à optimiser les flux de travail. L'offre comprend des produits et des solutions pour les soins intensifs, les procédures cardiovasculaires, les salles d'opération, la stérilisation et les sciences de la vie. Getinge emploie plus de 12.000 personnes dans tout le monde et ses produits sont vendus dans plus de 135 pays. Avantages chez Getinge: Chez Getinge, nous offrons un ensemble complet d’avantages, qui comprend: <ul> <li>Assurance santé, soins dentaires, soins de la vue et assurance voyage</li> <li>Régime de pension agréé avec contrepartie de l'entreprise</li> <li>Congé rémunéré</li> <li>Initiatives de mieux-être et ressources d’aide à la santé</li> <li>Assurance vie</li> <li>Prestations d’invalidité de courte et de longue durée</li> <li>Régime de travail hybride (le cas échéant)</li> <li>Congé parental et congé pour proches aidants</li> <li>Remboursement des frais de scolarité</li> </ul> Getinge est un employeur offrant l'égalité des chances. Getinge se conformera en tout temps à toutes les lois applicables en matière de droits de la personne et autres lorsqu’il examinera tous les candidats qualifiés pour un emploi. Des mesures d’adaptation sont offertes sur demande aux candidats qui participent à tous les aspects du processus de sélection.

Quality Manager - GTA (Mississauga, CA) @ Getinge Holding B.V. & Co. KG

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