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Manufacturing Specialist Full Time NEW
Position Summary:
The Manufacturing Specialist shall support day-to-day manufacturing and inspection activities of ABK
Biomedical products and the introduction of new product lines compliance with good manufacturing
practices (GMPs).
Key Responsibilities:
The key responsibilities of the Manufacturing Specialist are, as follows:
• Perform routine, high-temperature manufacture of glass microspheres by following released
procedures.
• Perform precise and repeatable assembly of medical devices in a certified cleanroom based
environment.
• 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.
Experience Required:
Basic Qualifications include:
• 3 years experience in glass manufacturing and delivery device manufacturing
• 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.
• English language – speaking, reading, writing
• 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.
Desirable Qualifications include:
• 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.