Our mission is to Profoundly change the standard of care by creating a tomorrow where clinicians can confidently ablate tissue with precision; a tomorrow where patients have access to safe and effective treatment options, so they can quickly return to their daily lives. Changing the standard of care is part of our fabric. We are a group of energetic, problem-solvers focused on innovation, and looking to change the world. We are changing the paradigm for treating diseases such as prostate cancer by using real-time MR Imaging, thermal ultrasound and close-loop temperature feedback control, to gently ablate the diseased tissue with minimal side effects.
If you share our values and want to work in a collaborative results focused culture and want to make a Profound impact in healthcare and your career, here is your chance.
General Accountability:
Support the Manufacturing, Materials Group and Quality department as required in all aspects of inventory management, quality control, quality assurance and regulatory compliance activities.
Duties and Responsibilities:
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Contribute to a positive, high-performance team environment;
- Provide support to manufacturing and purchasing through inspection and auditing of incoming material for conformance to product specification, purchasing specifications, as well as Food and Drug Administration to GMPs and ISO 13485;
- Performs timely First Article Inspections, and Incoming Inspections using mechanical and measuring equipment to ensure conformance to part/product specifications and requirements;
- Maintain control of equipment requiring calibration and preventative maintenance. Coordinate calibration of equipment with manufacturing engineers and procurement team. Coordinate preventative maintenance work with manufacturing engineers;
- Maintain control of materials used in manufacturing.
- Prepare and review shipment of product to sterilization;
- Actively supports quality control and continuous improvement through participation in engineering changes and other improvement programs;
- Will also assist in supplier evaluation through data collection of inspection results;
- May be required to do special testing, engineering support work, and other quality control and quality assurance activities;
- Writes first article inspections, incoming inspections, work instructions, procedures, and special instructions as required;
- Assists in In-process/Final Inspection as required;
- Take on special assignments as warranted;
- Work with receiving, finance and purchasing to reconcile discrepancies in receiving and invoicing;
- Adheres to and supports the Quality Policy as well as all ISO-13485 Quality System procedures and guidelines;
- Maintain Metrics;
- Support Lean activities and initiatives;
- Support EHS activities and initiatives;
- May be asked to handle some shipping and receiving tasks;
- Perform other duties/special projects as assigned.
Education and Certification:
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College or University Degree or at least 3 years of experience with inspecting parts using measurement equipment in an ISO 9001 environment
Key Attributes (experience, skills and technical knowledge):
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Exposure to ISO 9001 quality system minimum. Preferred, exposure to ISO 13485 standard;
- Ability to read and understand part drawings and written specifications;
- Ability to interpret technical drawings, dimensions, tolerances, etc;
- Ability to interpret circuit schematics;
- Employs a results-oriented work style and teamwork-oriented approach to meeting objectives;
- Demonstrates the ability to prioritize duties, multi-task, and quickly assume new tasks to function productively in a fast-paced environment;
- Proven ability to establish working relationships with design engineers, sustaining engineers, manufacturing engineers, production technicians, procurement team, QC personnel, and QA personnel;
- Strong communication skills, written and oral;
- Possess excellent attention to detail to ensure accuracy
We thank you for your interest in Profound Medical. Please note only candidates that are short-listed will be contacted.
We strive to promote diversity and equal opportunity in the workplace and encourage applications from all qualified individuals, including those with disabilities. If selected to participate in the recruitment, selection, and/or assessment process, please inform Human Resources of the nature of any accommodation(s) that you may require.
