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Qvella Corporation Director, Manufacturing Sciences & Engineering in Richmond Hill, Ontario

An exciting opportunity for Director, Manufacturing Sciences & Engineering. This is a permanent opportunity with Qvella Corporation located in Richmond Hill, Ontario.

Nature and Scope of Work:

In this leadership role, the Director will be responsible for the development and implementation of the design transfer processes to manufacture FAST-Technology™ (Field Activated Sample Treatment) products, including reagents cartridges and instruments at the Richmond Hill facility. This individual will define and direct the activity with internal stakeholders to plan, execute, and document early manufacturing that define the product and process of new products. Additionally, the Director will be responsible for any sustaining activities related to process and product improvements. The Director will oversee a team of Engineers and Scientists that make up the Sustaining and Design Transfer activities.

Essential Duties and Responsibilities:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily:

  • Provide direction and oversight for validation activities such as process, equipment and manufacturing validation

  • Responsible for documentation review to ensure compliance with ISO13485 requirements

  • Provide oversight and prioritization on CAPA actions related to manufactured product

  • Liaise with stakeholders to improve productivity, quality, and drive process improvements, specifically around design transfer activities

  • Identifying and implementing potential process improvements in conjunction with Manufacturing Operation

  • Assist manufacturing by leading investigations in partnerships with Manufacturing, Quality, Product Development and Field Service, to determine root cause for variation, implement solutions, and ensure corrections are effective.

  • Proactive issue identification and risk management across the manufacturing process

  • Institute Best Practices and lessons learned in similar industries

  • Provide day-to-day leadership, clear direction, guidance and performance feedback to direct reports; Focus on developing and coaching team

  • Other related duties as required.

Qualifications and Requirements:

  • 12+ years of industry experience, specifically around product transfer to manufacturing

  • 8+ years of leadership experience managing teams

  • Familiar with global IVD regulations related to instruments and consumables, validation/qualification requirements

  • Excellent communication skills and attention to details.

  • Strong organizational skills and ability to multi task across projects and activities

  • Proven ability to build effective teams and participate on multi-disciplinary teams

Education: Minimum B.Sc. degree in engineering such as: electrical, mechanical, biomedical, or related technical field, Master’s degree or PhD preferred.

What are you waiting for? Apply Now!

Qvella is an equal opportunity employer. We are committed to a diverse and inclusive workplace for all. If you are selected to participate in the recruitment process, please inform us of any accommodations you may require. Qvella will work with you in an effort to ensure that you are able to fully participate in the process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.

Must be legally eligible to work in Canada at the location(s) specified above and, where applicable, must have a valid work permit or study permit that allows the candidate to fulfill the requirements of the role.

We thank all interested applicants; however, only those selected for an interview will be contacted.

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