At ABK Biomedical, based in Halifax, Nova Scotia, we’re transforming interventional radiology through the development of proprietary embolization technologies that enhance the treatment of hypervascular tumors and improve patient outcomes.
Led by a seasoned leadership team, backed by $30M in recent Series B funding, and driven by a talented group of scientists, engineers and support personnel, we’re poised to commercialize our novel radiopaque microspheres technology throughout multiple markets.
We’re searching for a driven, conscientious manufacturing professional with a keen awareness of safety, quality and continuous improvement. In this role, you’ll support the day-to-day manufacturing and inspection activities of ABK Biomedical products and the introduction of new product lines, in compliance with good manufacturing practice (GMP).
- Perform routine, high-temperature manufacture of glass microspheres by following released procedures.
- Conduct materials characterization and inspections on in-process and finished product to ensure product meets specification and standards.
- Ensure that products meet the highest standard of quality, and are produced on schedule.
- Generate and complete required documentation for the Device History Record (DHR) in a timely manner with adherence to good documentation practice (GDP).
- Offer suggestions on improvement of processes and methods.
- Assist in creating and updating process and product documentation.
- Provide support to teams, including performing non-routine duties related to quality improvement, cost/cycle reduction, method development/improvement, process optimization studies, validation projects or new product introduction.
- Keep work areas clean, organized and safe.
- Perform all duties safely and in compliance with the US FDA Quality System Regulations, Canadian Medical Device Regulations, and all other regulatory requirements with which ABK Biomedical complies.
- Adhere to ABK Biomedical procedures, including quality and safety procedures.
- Communicate observations and data regularly in meetings and reports.
- Must be available to work overtime as requested by management in order to meet business needs.
- Post-secondary education, preferably in a technical/science discipline.
- Self-motivated, with the ability to multi-task and work without direct supervision.
- The ability to work cohesively with a cross-functional team in a fast-paced environment.
- Excellent analytical, training and communication (verbal and written) skills.
- Excellent listening skills and razor-sharp attention to detail.
- Willing and able to master new skills.
- Strong mechanical aptitude, dexterity and eye-hand coordination.
- The ability to reach, bend and lift daily, and work with a high-temperature oven, materials and open flame.
- Proficient with various types of software.
- Experience working in a regulated manufacturing environment, preferably with ISO 9001 or ISO 13485 certification.
- Previous experience with the following materials characterization techniques: XRD, DSC, helium pycnometry and SEM.
To apply for this role, please submit your application through our job posting site here. We thank all applicants for their interest; however, only those selected for an interview will be contacted.
ABK Biomedical is an equal opportunity employer and accommodates people with disabilities throughout the recruitment and selection process.