An exciting opportunity for Quality Engineer. This is a permanent opportunity with Qvella Corporation located in Richmond Hill, Ontario. Nature and Scope of Work Responsible for driving product quality improvement while conforming to regulated QMS processes. Working with a cross-functional team with a focus on product and process efficiency, reliability and performance in accordance with company\xe2\x80\x99s quality manual and procedures. Note that the title \xe2\x80\x9cEngineer\xe2\x80\x9d will be conferred if the candidate has the required qualification. Otherwise, a different title, consistent with the level of the role, will be chosen. Essential Duties and Responsibilities

• Work closely with product development and manufacturing engineering teams to ensure timely development and deployment of design transfer protocols/specifications and release activities for production and service
• Develop inspection methods to analyze product quality
• Improve product quality by making recommendation for change
• Ensure products adhere to company and industry quality standards
• Investigate customer complaints and non-conformance issues
• Work with all stakeholders to create solutions for identified quality problems
• Provide support to delivery, drive and maintain effective product quality surveillance
• Analyze data to highlight trends that indicates the need for manufacturing process and specification changes
• Review and approve documents for compliance to quality standards as required, including design/production/service documentation
• Support post-market surveillance and KPI programs
• Support supplier qualification and monitoring
• Other related duties may also be assigned

Qualifications and Requirements

• Minimum of 3 years\xe2\x80\x99 hands-on experiences in quality engineering, control and improvement preferably in the medical device, life science, or pharmaceutical industry.
• Excellent English verbal and written skills, strong MS office skills
• Highly proficient in design, process and quality documentation
• Organized, meticulous, motivated to achieve goals.
• Work effectively and independently, a strong teamwork approach and a desire to work in a fast paced growing environment.
• The ability to use metrology and statistical methods to diagnose and correct improper quality control practices
• Experience with product reliability and design improvement
• Knowledge of Health Canada, FDA, EU regulations, ISO 13485 and MDSAP standards is an asset.
• Preferences will be given to candidates with certifications for quality audit, quality engineer, quality improvement associate, Six sigma

Other Job Requirements

• Multi-task various projects/timelines at one specific time.
• Professional approach and appearance.
• Capable of delivering results in a dynamic work environment
• May include travel, when necessary

Education

• Bachelor or Master degree in engineering, science and life science.

In support of our commitment to a healthy and safe workplace, Qvella Corporation has a vaccination requirement as a condition to the offer of employment. Fully vaccinated is defined as having received a completed series of an accepted COVID-19 vaccine, as recommended or approved by Health Canada and having received the final dose at least 14 days before your employment start date. Ongoing boosters may be required in the future as a continuing condition of employment, as they are announced by Health Canada. We will provide a full copy of our policy at the time of offer. The candidate will be asked to provide Qvella with proof of full vaccination, prior to their employment start date. Acceptable proof is a Ministry of Health Dose Administration Receipt. This can be obtained through the Provincial portal at https://covid19.ontariohealth.ca/. We will also accept out of province vaccination records, provided they have the same information included in the Ministry of Health Dose Administration Receipt. This includes the type of vaccine, date of each dose and sufficient identification information to connect the receipt to the candidate. The requirement to be fully vaccinated is subject to the Ontario Human Rights Code. If the candidate is unable to vaccinate for a reason protected by the Code, a request for accommodation can be made upon written proof, satisfactory to the company.
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. oXp5onVPpQ