Quality Engineering Specialist

At Young Innovations, we foster a dynamic environment where team members make an impact every day as part of a collaborative, inclusive culture. Together, we serve the dental profession and their patients, united in our mission of achieving a Lifetime of Oral Health™

At Young Innovations, we foster a dynamic environment where team members make an impact every day as part of a collaborative, inclusive culture. Together, we serve the dental profession and their patients, united in our mission of achieving a Lifetime of Oral Health™

We embrace diverse perspectives and encourage bold thinking, challenging traditional approaches with a bias for action. Whether you’re looking to expand your skills or grow your career, Young is here to support your goals and continuous learning. At Young, YOU are at the core of what we do.

Germiphene Corporation, a Young Innovations company and a Health Canada-licensed manufacturer of dental pharmaceutical, natural health and medical device products, is hiring a Quality Engineering Specialist. Reporting to the Quality Manager, this role is the site owner of all Process Validation, Equipment Control, and Preventive Maintenance Programs, and keeps those programs in a state of continuous compliance with Health Canada GMP, ISO 13485 and regulatory requirements.

• You will own validation and qualification end to end: risk assessments, determining critical process parameters and acceptance criteria, drafting protocols and statistical sampling plans, directing protocol execution on the floor, interpretation of data, and finalizing reports.
• You will keep the site's equipment validation, calibration and preventive maintenance program in a state of compliance and are responsible for monitored systems, including the USP Purified Water System.

• You would rather propose the technical approach and defend it than wait to be handed a method.
• You like the discipline of validation work: define the parameter, prove the control, and write it up so it holds up three audits from now.
• You want to own programs rather than work a task queue.
• You can carry a concurrent portfolio of protocols, qualifications, change controls and CAPAs to agreed dates, coordinating work that depends on Production, Packaging, Maintenance, QC, Microbiology and R&D.
• You want the impact of your work to be visible. There is no separate validation or metrology group here, so the technical decisions and the programs are yours.

• Medium sized company, not too big, not too small, just enough to get things done and see your impact.
• Did we say benefits? Health, dental, and vision coverage; group RRSP; parental leave; statutory holidays; paid time off; short- and long-term disability insurance; employee assistance program; and more.
• Real ownership from day one. You are the site owner of validation, calibration and preventive maintenance: you set the technical approach, issue the protocols and reports, and your qualification decisions define how the equipment runs.

• You will report to the Quality Manager. The position has no direct reports and works daily across Production, Packaging, Maintenance, Quality Control, Microbiology, R&D and Regulatory Affairs at the Brantford site, as well as with Young Innovations corporate Quality counterparts at our sister facilities.

• Validation and qualification
  • Own process validation under the Validation Master Plan: evaluate manufacturing processes to determine critical process parameters, develop protocols and acceptance criteria, apply statistical techniques to set sampling plans, manage execution on the floor, interpret the resulting data, and issue approved…