Working at MedXL
Make a difference
When enhancing lives is your quest, your work is meaningful, your contributions significant, and your curiosity is driven by limitless possibilities, that’s MedXL. Here your compassion, commitment and delivery of results will take us far. Together, we can make a difference in healthcare around the world.
MedXL is committed to employment equity
MedXL is committed to employment equity and encourages applications from women, members of visible minorities and persons with disabilities. As an equal opportunity employer, we are committed to fair employment practices to ensure that qualified candidates have access to employment opportunities and that hiring decisions are made on the basis of merit.
Interested in joining MedXL? Email your resume to us and we’ll contact you when appropriate openings occur.
Product Development Coordinator
Reports to (title):
Product Engineering Manager
Under the direction of the Product Engineering Manager, the candidate brings technical expertise to the company’s product design and development operations. This position collaborates with all business departments of the company to manage and support product design and development projects at our MedXL facilities. The role includes coordinating and executing product design and development projects from concept to implementation, interfacing with vendors and customers as needed, and managing post-market changes related to product design.
- Read and understand the requirements given by the immediate superior.
- Project planning, establishing requirements, and developing product specifications.
- Select and qualify the material required for product development.
- Develop and manage risk analyses.
- Produce prototypes in collaboration with the production department.
- Participation in the evaluation of processes and equipment related to product development.
· Plan and execute design checks and validations; adjust the design as required.
· Issue master documentation (materials and products).
· Perform related tasks in product development.
• Engineering degree or equivalent training in medical devices or pharmaceutical options.
· Minimum 2 years of relevant experience in product development. (Development of pharmaceuticals / medical devised preferred).
Habiletés/qualifications: Skills / Qualifications:
• Experience in regulated environments. (cGMP, FDA, ISO 13485)
• Knowledge of the processes and regulations of medical or pharmaceutical devices.
• Able to analyze, synthesize and solve problems.
• Knowledge of CAD (SolidWorks) an asset.
• Member of the OIQ or eligibility an asset.
• Able to work on multiple projet and meet deadlines.
• Ability to work in multidisciplinary teams.
• Motivated with ability to achieve goals.
• Customer orientation, good interpersonal relations.
• Adaptable, autonomous, diligent and meticulous.
· Perfectly bilingual in English and French (oral and written).
Schedule 35 hours
Saturday & Sunday, 8:30am to 6:30pm
Evening bonus (when applicable): $0.70/hour
TITLE : Inspector Quality Operations
DEPARTMENT : Quality Operations
SUPERVISER TITLE: Supervisor
TASKS AND RESPONSIBILITIES
To plan work according to the calendar of the tests.
· To carry out the tests in necks of production, to supplement the documentation of tests and to classify documentation.
• Control and release raw material.
· To carry out the tests on the products finished for the slackening of the batches of production,
· To ensure themselves of the conformity of the products and to emit the certificate of analysis.
· To take part in the resolution of problems and the decision-making relating to the inspections carried out.
· To carry out environmental controls (microbiological, particulate, temperature, moisture and pressure).
· To see the data of particulate controls of the environment for the night shift. To record the data in the corresponding documents and to subject them to the service of quality assurance for counter-checking.
· To analyze the samples turned over by the customers following complaints customers.
· To take part in the selection and the approval of new components
· Person in charge for the development of the tests of quality control for the components used in manufacture in collaboration with engineering and the quality assurance according to the normative requirements.
· To produce the drawings of assembly of the new products according to components' provided by engineering.
· To coordinate the tests of laboratory.
· To take part in development of the tests of quality control for the finished products and in the course of production in collaboration with engineering and the quality assurance according to the normative requirements.
· Person in charge for the update of the table of the products classified according to the factor of risk (measurement of surfaces of the products, weight of the products and the components and component count per product).
· Responsible for the change request and the non-conformity.
· To write and revise the check procedures quality.
· To take part in the meetings of the department.
· To carry out all other related tasks.
· To have DEC in sciences and to have 2 years minimal experience as inspector quality control or quality assurance or to have a Baccalauréat in sciences or equivalent diploma.
· To have good knowledge of the current software of office.
· To be bilingual with the writing.
· To control good manufacturing practice.
· To know the standard ISO 13485.
· To know good manufacturing practice (BPF).
· To be adaptable, assiduous, meticulous.
· To be able to learn and work in team.
· To have good capacities of analysis, the initiative, judgment, a good organization of work.
· 6 months.
TÂCHES ET RESPONSABILITÉS
· Responsable du suivi des requêtes de changements et des non-conformités.
· Rédiger et réviser les procédures d’assurance qualité et contrôle qualité.
· Responsable de la formation du nouveau personnel du département sur les systèmes qualité implantés.
· Responsable de la gestion documentaire du système qualité afin qu’elle soit conforme aux normes et règlements.
· Participer à la qualification et la sélection des fournisseurs en collaboration avec l’ingénierie et les achats.
· Gérer les plaintes des fournisseurs et des clients.
· Faire le suivi des CAPA.
· Participer aux dossiers de validation de processus.
· Participer à la rédaction des procédures d’opérations normalisées (PON).
· Vérifier le dossier de fabrication pour le relâche des lots de fabrication et émettre le certificat de conformité.
· Participer aux audits internes et externes.
· Faire le suivi d’audit de la dose de stérilité.
· Participer aux réunions du département.
· Faire le suivi de la stabilité permanente.
· Effectuer les KPI
· Effectuer la surveillance post-commercialisation.
· Soutien de Contrôle de qualité dans le cas de besoin.
· Effectuer toutes autres tâches connexes.
· Posséder un B.Sc et avoir une expérience minimale de 2 ans comme coordonnateur en assurance qualité
· Avoir de bonnes connaissances des logiciels de bureau courants.
· Maîtriser les bonnes pratiques de fabrication.
· Être bilingue à l’écrit.
· Maitrise les normes 13485 :2016, CMDR, CFR21PART820, MDD 93/42/EEC,
· Être adaptable, assidu, résistant au stress, minutieux.
· Être capable d’apprendre et de travailler en équipe.
· Avoir de bonnes capacités de travail et d’analyse, de l’initiative, du jugement, une bonne organisation de travail.
· 6 mois.
Complete scheduled preventive maintenance tasks. Perform corrective and emergency repairs during day-to-day operations with a focus on maintaining production Complete equipment settings and format changes. Collaborate with production staff to identify the priority of intervention based on the duration of the work and the production needs. Collaborate with the production engineer on ongoing improvement projects as well as work performed by external suppliers. Document the work performed on the equipment, including the condition of the equipment, a shift and the parts used during repairs. Application and compliance with health and safety rules and regulations Any other related tasks.Electromechanical graduate Minimum of 3-5 years as a maintenance technician in a related field Periodically available for overtime to support production operations Excellent approach to solving mechanical and electronic problems Capable of diagnosing API relay logic Able to work under pressure with tight schedules. Able to coordinate the work of other maintenance technicians. English and French, spoken and written an asset.During the growth of the maintenance service, will have to respond to emergencies on call.6 months probation period2 positions to fill:1 day shift 6:40-2:40pm1 night shift 10:40-6:40am
TITLE : Technician
DEPARTEMENT : Manufacturing
SERVICE : Prefilled Syringes
10:40PM to 6:40AM, Sunday to Friday
37,5 hours paid per week
SUPERVISOR TITLE : Team Leader
TASKS AND RESPONSIBILITIES
· Check the work on the billboard.
· Check the tickets on the approved products.
· Supply the machine with tickets.
· Carry out the filling of syringes by machine (hopper) and by hand.
· Put aside syringes at the beginning, the middle, and the end to be sampled by quality control.
· Check the tickets applied on the syringes and count the rejects.
· Fill the syringes on the pump.
· Check the syringes (for dirt, level of liquid).
· Put the caps on syringes and then put them in the bin.
· Take the bins when filled with syringes and put the bin at the proper place.
· Make sure of the availability of the raw material and the supplies.
· Pack the syringes with the appropriate equipment.
· Check the lot, and the printing on the ticket.
· Place product in box, tape the top and put the sticker on the box.
· Count the boxes.
· In some case pack the product manually for certain products.
· Operate various machines.
· Respect the company policies.
· Carry out maintenance of the equipment and your working area.
· Apply the regulations of health and security at work.
· Apply the regulations regarding contamination in the company.
· Perform all related tasks.
· Having a secondary 5 minimal.
· No experience required.
· Impeccable personal hygiene.
· Diligence, adaptability, punctuality, meticulous and responsible.
· Good manual dexterity and good organizational skills at work.
· Capable of working with a team.
· Reach a good execution speed.
· 3 months