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.
TASKS AND RESPONSIBILITIES
· Design, develop and manage new and existing medical electrical devices, products and systems
· Plan, organize, manage and lead work meetings related to the projects
· Prepare product engineering drawings and prototypes
· Produce and maintain Material and Device Master Records (MMRs/DMRs), and Design History Files (DHFs)
· Perform and manage Risk Management, Verification and Validation activities
· Manage Design Transfer of development products to manufacturing
· Post market management of the product design and future Engineering changes
· Perform all other related tasks
· Bachelors in Biomedical or Electrical Engineering, or relevant work experience
· Minimum 3 years of experience developing medical electrical devices
· Good understanding of industry related standards
o IEC 62304 – Medical device software – Software life cycle processes
o IEC 60601 (series of standards) – Medical electrical equipment: Requirements for basic safety and essential performance
o ISO 14971 – Risk Management
o ISO 13485 – Medical devices: Quality management systems
· Good knowledge of Office (word, excel, outlook)
· Good project management skills
· Good communication skills
· Bilingual (English and French)
· Good decision making and problem solving skills
· Organized and autonomous
· 6 months
TASKS AND RESPONSIBILITIES
- Preventive maintenance and inspection of equipments.
- In production repairs.
- Capable to diagnose a PLC (programmable logic controller).
- Equipment set-ups and format change-overs.
- Maintains the lists of parts and tools required by each equipment.
- With the production engineer, controls the progress and quality of technical work done by external suppliers.
- Documents the work done on the production equipment.
- To carry out all other related tasks.
- Electromechanical diploma
- Good technical problem solving approach
- Teamwork oriented
- Capable of working under pressure with tight schedules.
- Auto discipline: capable of working under light supervision.
- Able to coordinate the work of other maintenance technicians
- During the expansion of the service, will have to be available on call.
- Must organise routine work to fill a 40 hours timetable per week.
- 6 months
TITLE : Quality Operations Coordinator
Department: Quality Operations
SUPERVISOR TITLE : Supervisor
TASKS AND RESPONSIBILITIES
· Understand the priorities assigned by the supervisor.
· Plan the work according to the schedule of the tests.
· Perform tests during production, complete documentation for the tests and classify documentations.
· Perform the tests on finished products for production lots to be released.
· Ensure compliance for the products and issue the certificate of analysis.
· Participate in problem-solving and decision-making relating to inspections carried out.
· Perform environmental controls (microbiological, particulate, temperature, humidity and pressure).
· Read data from environmental particulate controls.
· Save the date in the corresponding documents and submit them to the service of quality operations for cross-checking.
· Analyze the samples returned by the customer after customer complaints.
· Participate in the selection and approval of new components.
· Responsible for the development of the quality control tests for components used in the manufacture in collaboration with engineering and quality operations according to the normative requirements.
· Produce the assembly drawing of new products according to the components provided by engineering.
· Coordinate laboratory tests.
· Participate in the development of the quality control tests for finished products and production in collaboration with engineering and operations quality according to the normative requirements.
· Responsible for the update of the classified products table to the risk factor (measure of the products surfaces, products and components weight and number of components by product).
· Responsible for the follow-up of requests for changes and non-conformities.
· Write and review of quality operations procedures.
· In charge of training new department employees on the implemented quality system.
· Responsible for managing the quality system documents to ensure that it complies with the standards and regulation.
· Responsible for the follow up of the documentary change requests approved by the supervisor.
· Participate in qualifying and selecting suppliers in collaboration with engineering and procurement.
· Manage complaints from suppliers and customers.
· Follow up on CAPA and non-conformities.
· Participate in the validation of process records.
· Participate in the drafting of procedures for standard operations (PON).
· Verify the fabrication file to allow the release of the fabrication lots and allow issuance of certicate of conformity.
· Participate in internal and external audits.
· Follow up of sterilization dose audit program.
· Be part of the department meetings.
· Perform all other related tasks.
· Retain a DEC in science and have a minimum of 2 years’ experience in quality field or retains BSC diploma in science.
· Retain good knowledge of current business software.
· To master the good manufacturing practices (GMP).
· To be able to write French and English.
· To have knowledge of the 13485 standard.
· To be adaptable, on time, stress resistant and meticulous.
· To be able to learn and to work in a team.
· To have good working and analysis capacities, initiative, judgment and a good working organization.
· 6 months.