Kardium is a technology pioneer developing devices to address cardiovascular diseases. The company was founded in 2007 by a team with a track record of excellence in medicine, business, and engineering. Focused on building a world-class, internationally dominant medical device company, we believe in having lots of fun while working hard. We hire top individuals who are strong team players and trust them to make the right decisions to achieve our goals. In the 2012 BC Business "Best Companies to Work for in BC" survey, Kardium was voted the #1 Health Sciences & Services Company for the third year in a row, and the #2 company overall for the second year in a row . Visit our website at: www.kardium.com.
Kardium offers a flexible work environment, a comprehensive salary and benefits program.
About the Job:
Kardium currently has an exciting opportunity for an experienced and motivated Sr. Quality Engineer to join our world-class team in the development of Kardium's novel catheter for percutaneous treatment of atrial fibrillation. This is a full-time, permanent position.
In close cooperation with the research, engineering, and manufacturing teams, the Senior Quality Engineer will lead quality planning and implementation efforts to support successful new product launches. The position offers an opportunity to plan and lead aspects of quality assurance, and a chance to be involved in hands-on quality engineering of cutting-edge medical devices. The Sr. Quality Engineer will work under only general direction and will independently determine and develop approaches to quality planning and process control development, implementation and improvement.
The role will evolve over the product life cycle with the initial focus on supporting design verification and validation testing and ensuring consistent quality of devices produced for pre-clinical and early clinical testing, then shifting to manufacturing and operations support in the later stages of the commercialization process. The successful candidate will apply their ISO13485 / U.S. FDA QSR experience and their quality engineering knowledge to ensure excellent communication between the Quality Assurance and Regulatory Affairs (QA/RA) Team, the Manufacturing Team, and the Engineering Team.
In the design and development phase, participate in Design Control activities in close collaboration with design engineers and other functional stakeholders in order to:
• Identify safety and performance-critical components and their key characteristics along with applicable tolerances.
• Liaise with risk management team to conduct DFMEA.
• Assist with V&V activities as required.
In the design transfer phase, partner with Engineering and Manufacturing to ensure products are effectively and appropriately transferred to internal or contract Manufacturing. Specifically:
• Liaise with all involved teams to conduct PFMEA.
• Plan, coordinate, and implement production process and production equipment controls.
• Develop Standard Test Methods and provide training.
• Lead the development of quality control procedures within the manufacturing process, with focus on the mechanical subsystems of the device.
• Help communicate expectations around quality control to suppliers, and coordinate part and process approval.
• Work with Manufacturing to solve in-house quality issues, review nonconforming product, and recommend disposition.
In the production phase, collaborate with all functional stakeholders in order to:
• Monitor product quality.
• Assess and monitor process stability using SPC.
• Establish process capability.
• Based on monitored data, provide solutions for corrections or improvements.
• Conduct nonconformity investigations, participating in root-cause analysis and recommending corrective action to prevent recurrence. Resolving vendor-related NCRs may require travel in Canada, USA, and globally on short notice.
• Participate in the assessment of post-market surveillance feedback and implement any resulting CAPAs or necessary improvements to process controls.
• Participate in in post-production risk management and ECR activities.
Experience and Qualifications:
• Education: Bachelor of Science degree (Mechanical, Applied Physics, etc.) or equivalent engineering degree.
• At least 5 years of QA/QC experience in a multi-disciplinary environment in a regulated industry, preferably in the area of high-risk medical devices.
• In-depth knowledge of metrology as well as quality planning, execution, coordination, and documentation.
• Sound knowledge of statistics, SPC, GD&T, FMEA, DOE, and process capability.
• Experience working in environments compliant with ISO 13485 and/or U.S. FDA QSR.
• Excellent written & verbal communication and technical documentation skills.
• Strong interpersonal skills with the ability to interface effectively across multiple functions and at various levels of the organization.
• Flexible and adaptable to take on additional responsibilities as appropriate.
• Ability and willingness to travel to vendor sites within North America and overseas as required.
To apply for this position, please send a résumé and cover letter to firstname.lastname@example.org, with the job title "Senior Quality Engineer" in the subject line.