- Type: Contract
- Length: 12-18 months with opportunity for conversion to full-time
Education and Qualifications
- Bachelor degree in Biology, Biochemistry, Biomedical Sciences or related field (Required)
- 1 -3 years’ experience in customer service (preferred)
- Excellent oral and written communication skills
- Receives, processes and verifies the accuracy of orders from customers utilizing the organization’s internal systems and customer purchase orders
- Initiates required action for response to customer service requests for order changes, including the maintenance of order and communicates changes to the appropriate personnel/departments
- Provides technical support to customers by identifying problems; researching answers; guiding customer through corrective steps.
- Performs investigation of product complaints
- Resolve problems, facilitate solutions and enhance customer service offerings
- Provide back-up support to coworkers in the performance of job duties required
- Answers customer inquiries/communications as required
- Oversee assigned projects from initiation to completion; setting timelines and targets to ensure the projects progress in a timely manner
- Communication with senior management for regular updates regarding project statuses
- Documenting and prioritizing tasks, in consultation with management
- Develop international customer and distributor relations
- Ad hoc projects that arise in the regular course of business
- Become familiar with proposed new product; its function, purpose, and value to end-users
- Conduct analysis to determine best implementation procedure for product into clinics and laboratories
- Performs other related duties assigned by management
- Ideal candidates can adapt easily to change, have the ability to think logically, be a problem solver, communicate effectively and professionally and follow process documentation closely
- Project management skills & business acumen
- Strong analytical skills, being able to interpret business needs into actionable items
- Very strong initiative
- Excellent creativity & resourcefulness
- Organized and ability to multi-task
- Detail and results-oriented
- Strong time management skills
- Superior written and verbal communication skills
- Able to work independently and as a team to complete tasks within deadlines
- High proficiency in MS Outlook
Application and Details
Do you have what it takes? Tell us why you are awesome and why you want to work for BTNX Inc. by submitting your resume and cover letter to firstname.lastname@example.org. We can’t wait to hear from you!
BTNX is seeking a Quality Assurance and Regulatory Affairs professional to lead the maintenance and improvement of BTNX’s QMS and ensure compliance with applicable regulatory requirements.
- Ensure the promotion of awareness of applicable regulatory requirements and quality management system requirements throughout the organization
- Develop and in depth knowledge of BTNX’s Quality Systems, including Quality Policy, Quality Manual and all Standard Operating Procedures
- Ensure all facility and product registrations are current i.e. Health Canada, FDA, CE mark
- Identify any Corrective/Preventive Actions required and ensure the actions are implemented effectively
- Lead internal audits
- Organize and partake in Management Review meeting(s)
- Report to Top Management on the effectiveness of the quality management system and any need for improvement
- Prepare regulatory license submissions for medical devices in Canada, US and other territories.
- Write and approve procedures, work instructions and other quality documents as necessary.
- Oversee complaint investigations
- Review and approval of content for Product Labeling
- Performs recalls and medical device reporting when necessary
- Bachelor’s degree in a Scientific//Life Science discipline.
- 2-5 years of relevant experience.
- Knowledge of FDA, Health Canada, and European in-vitro diagnostic medical device regulations
- Quality Assurance training – ISO13485:2016 (preferred)
- Experience in the medical device industry (preferred)
- Ability to work independently with little supervision and working as part of a team.
- Ability to perform detail-oriented work with a high degree of accuracy.
- Willingness to be flexible and adaptable to changing priorities.
- Excellent oral and written technical communication skills.
- Ability to drive results, foster teamwork, handle multiple projects, and provide feedback
- Proven ability to work cross-functionally in a team based environment.
We are a company that values dedication, resourcefulness and results, and looks to foster the entrepreneurial spirit in all our talent. If this is something that speaks to you, please submit your resume and cover letter to email@example.com. We can’t wait to hear from you!