Medical Device Assemblers Jobs

Document review of product changes due to EU MDR impact and the management of any required submissions.

Extracting available documents from the document management databases and operational systems to assist in the preparation of dossiers.

Minimum of one year of working experience in Medical Device industry specific to Health Canada

Knowledge of ISO13485, EU MDD/MDR, and Health Canada MDEL/MDL applications is required

Strong organizational skills including attention to detail, good planning and communication skills are required

Must possess excellent written and verbal communication skills

· 10 to 12 years working experience

Experience working directly with the FDA on regulatory filings/strategy is required

· Experience with electronic submissions/the electronic submission process

Knowledge of how regulatory agencies operate, structure and process

Staying updated on regulatory requirements:

This is on site, 5 days a week role – for Canada, Scarborough location.

Minimum College education or Accredited Certificate program preferred, with certifications in ISO 13485, MDSAP, CE, and/or FDA regulations.

Participate in internal and external audits to ensure compliance with regulatory requirements.

Keep abreast of changes in regulatory guidelines and requirements, communicating these changes to the relevant teams.

Previous work experience in regulatory affairs within ISO certified companies is mandatory.

Minimum of 2 years of relevant experience in a similar role.

Medical device experience is necessary; understanding of medical device classifications and regulations is essential.

Previous Tech 2 experience in MDRC is essential

Applicants with previous Tech 2 experience in MDRC will be given priority

Broad knowledge of all surgical services and complex instrumentation

Prepares surgical case carts for regular specialized and emergency situations.

Operates decontamination equipment, prepares and packages sterile instrumentation/supplies, ensuring all quality indicators are met

Delivery and pick-up of supplies.

Previous Tech 2 experience in MDRC is essential

Applicants with previous Tech 2 experience in MDRC will be given priority

Broad knowledge of all surgical services and complex instrumentation

Prepares surgical case carts for regular specialized and emergency situations.

Operates decontamination equipment, prepares and packages sterile instrumentation/supplies, ensuring all quality indicators are met

Delivery and pick-up of supplies.

Previous Tech 2 experience in MDRC is essential

Applicants with previous Tech 2 experience in MDRC will be given priority

Broad knowledge of all surgical services and complex instrumentation

Prepares surgical case carts for regular specialized and emergency situations.

Operates decontamination equipment, prepares and packages sterile instrumentation/supplies, ensuring all quality indicators are met

Delivery and pick-up of supplies.

Operating room instrumentation experience essential

Recent work experience in a Hospital Medical Devices reprocessing department required (within the last two (2) years)

Applicants with previous Tech 1 work experience in MDRC at Sunnybrook will be given priority

Demonstrated excellent interpersonal and communication skills

Prepares surgical case carts and delivers to the OR

Prepares and packages sterile instrumentation/supplies, ensuring all quality indicators are met

Manage class and laboratory environments to ensure a safe, healthy and positive student learning experience

Preferred: Minimum of 1-2 years of teaching experience or preceptor mentoring, or clinical education

Prepare laboratory preps and supply lists for Educational Technologists

Collaborate with other faculty members and institutional partners to advance teaching methodology and educational technology, and to support student success

Leverage experience and areas of passion to help shape the future of learning at SAIT

Contribute to advancing the mission and vision of SAIT as being a global leader in applied education

Current CSA certification with relevant education.

Set up for lab experiences according to the course curriculum.

2+ years of experience in an MDRT-related position.

Interest in working in an education setting.

Experience working with online learning platforms.

Superior oral communication skills demonstrating the ability to articulate key messages effectively and employ active listening techniques.

Recent experience handling blood and body fluids and knowledge of routine practices

Previous experience and theoretical knowledge of proper method of working in an area of decontamination and sterilization of patient care items

Grade XII with excellent reading and writing skills

Successful candidate required to take and successfully pass a functional assessment to determine the physical capabilities to do the job.

A skill test will be included as part of the selection process

Ability to work in a fast-paced, physically demanding atmosphere

Knowledge of surgical and medical terminology.

Receives, sorts, disassembles, decontaminates, cleans, assembles, wraps, sterilizes, and stores instruments, equipment and hospital supplies from all user areas.

Operates departmental equipment such as automated washers, cart washer, pasteurizer, ultrasonic washer, clean dryer, heat sealer, and sterilizers.

Reports and/or removes any malfunctioning equipment or instruments.

Rotates stock and reprocesses outdated supplies according to departmental procedures.

Participates in the Department's Quality Assurance Program.

At least 3 years of relevant experience in medical device risk management

Leads Risk Management efforts, processes and process improvements for the Varian Products, with a main focus on Varian Digital Oncology.

Develops and maintains Risk Management Files that include risk management plans, hazard analyses and risk assessments

Keeps abreast of changes to regulations and standards as they bear on risk management

Minimum Required Skills And Knowledge

Bachelor’s degree in Science or Engineering with several years of related experience

Proven planning, organization and time management skills

Knowledge of or previous experience in nursing, infection control or microbiology

Minimum 9 months recent related experience an asset

Knowledge of sterile supply processing equipment, e.g. Steam Sterilizer, Cart wash, Amps Washer/Sterilizer, Ultrasonic, etc

Sound judgment and decision making skills

Grade 12 plus graduate of recognized Medical Device Reprocessing Technicians’ course

Knowledge of surgical and medical terminology.

Assists the Supervisor, MDR with timekeeping duties by entering information from work schedules into Meditech and forwarding to Payroll.

Participates in the maintenance of the procedure manuals by typing, cutting and pasting, photocopying, and filing new and/or revised procedures.

Creates and maintains computerized inventory of sterile supply instrumentation and tracks status of loaner instrumentation.

Maintains stationery and supply levels by monitoring stock, preparing order requisitions and storing supplies as required.

Answers the telephone, takes messages, answers routine enquiries and distributes mail.

Identify prospects, set appointments, make effective qualifying sales calls, and manage sales cycle to develop new business

Continuing development of product knowledge

1+ years of sales experience preferred

Maintain/developing working relationships with existing customers to ensure that they receive exceptional service and to identify potential new sales opportunities

Develop and execute effective business developments plans

Training and case support for operating room staff

Observes test procedures and product compliance to learn internal and industry specifications; applying knowledge and skill learned based on CEDO certification.

Knowledge of radiation safety and operational field requirements regarding radiation safety.

Operates exposure devices in compliance with the Canadian Nuclear Safety Commission regulatory requirements.

Strong technical knowledge and understanding of NDT techniques, services and procedures.

Excellent report writing and review skills.

Strong verbal and written communication skills matched with the ability to negotiate and build relationships with key stakeholders.

Knowledge of Medical Devices and Regulatory Requirements

Advise Project Management on correct shipping materials and documentation to order for global studies

Liaise closely with Project Management to ensure accurate address details in QLIMS

plays a key role in the ordering, management, and collection of worldwide field medical devices.

1-3 years of strong Global Shipping and Logistics experience is Required, preferably from another CRO or pharma company

Knowledge of Customs and International Shipping Regulations/Restrictions for Import/Export

Knowledge of Medical Devices and Regulatory Requirements

Participate in local vendor management meetings, promoting continuous improvement

Thorough knowledge of and current certification in international and domestic air transport regulations.

plays a key role in the ordering, management, and collection of worldwide field medical devices.

3-4 years of strong Global Shipping and Logistics experience is Required, preferably from another CRO or pharma company

Knowledge of Customs and International Shipping Regulations/Restrictions for Import/Export

Basic project management and interpersonal skills and the ability to understand scientific concepts

Knowledge of Canadian regulatory requirements in medical devices

Collect and organize information on regulatory requirements for in vitro diagnostic devices, quality, preclinical and clinical data to meet applicable regulations.

Participate in device registration activities - agency communication; registration requirements; participation in drafting and preparing submission documents

Bachelor’s or Master's degree with 2+ years of related work experience

IVD experience is an asset

SURGICAL TECHNOLOGY SPECIALIST, hiring in: LETHBRIDGE, ALBERTA

We provide a base pay, monthly auto, cell & parking allowances, commission, bonus and more.

If you wish to be considered for our team, please send your resume to: