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Position: temporary 1 year (maternity leave)
Department: Manufacturing Engineering
Schedule: 35 hours/week
Reports to (title):
Supervisor, Project Engineering
Reporting to the Supervisor, Project Engineering, the candidate provides technical expertise to the company's manufacturing operations. He/She will be responsible for production support and project management.
· Manage and develop projects related to production.
· Manage activities aimed at optimizing equipment.
· Prepare technical specifications, studies, budgets, and documentation related to projects.
· Develop procedures and configure equipment to meet specifications.
· Provide production personnel with training and documentation for any process changes.
· Ensure the application of standards; Quality, Health, Safety and Environment.
· Manage the engineering change control process.
· Manage projects related to atomization and vision systems.
· Undergraduate degree in engineering.
· 3 to 5 years of relevant experience in a manufacturing environment (pharmaceutical, food or cosmetic an asset).
· (Internship experience will be considered).
· Member of the Order of Engineers of Quebec (OIQ) an asset.
· Experience in project management.
· Knowledge of automation (Rockwell) an asset.
· Good knowledge of manufacturing equipment and processes.
· Knowledge of Six Sigma and Lean methods.
· Experience in a regulated environment (cGMP, FDA).
· Recognized for your strong motivation and ability to achieve objectives, your customer orientation, as well as your interpersonal relationships.
· Ability to manage several files at the same time in a changing environment.
· Fluent in French and English both orally and in writing.
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.
Responsible for tracking requests for changes and non-compliance. Write and revise quality assurance and quality control procedures. Responsible for training the department's new staff on established quality systems. Responsible for the document management of the quality system so that it complies with standards and regulations. Participate in the qualification and selection of suppliers in collaboration with engineering and procurement. Manage complaints from suppliers and customers. Track CAPA. Participate in process validation files. Participate in the drafting of standard operations procedures (PON). Check the manufacturing record for the release of the manufacturing lots and issue the certificate of compliance. Participate in internal and external audits.Follow up on the sterility dose. Participate in department meetings. Track permanent stability. Perform KPIs Perform post-marketing monitoring. Quality control support in case of need. Perform all other related tasks.Qualifications Have a B.Sc and have a minimum of 2 years of experience as a quality assurance coordinator Have a good knowledge of current desktop software. Mastering good manufacturing practices. Be bilingual in writing. Mastering Standards 13485:2016, CMDR, CFR21PART820, MDD 93/42/EEC, requirements Be adaptable, diligent, stress-resistant, meticulous. Be able to learn and work as a team. Have good work and analysis skills, initiative, judgment, good work organization.
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