Senior Quality Engineer

About the company

Most of the chemistry is done in-house, with animal studies run by a CRO. Founded in 2005, we now have 23 employees. Manufacturing runs 24/7 on 12-hour rotating shifts.

Fraser Pharmaceuticals is hiring a Senior Quality Engineer to support production and handle customer complaints at our Toronto plant. Hybrid, with three days a week in our Toronto office.

Responsibilities

• Review and approve PPAP submissions from suppliers.
• Support customer and registrar audits.
• Chair MRB meetings and disposition nonconforming material.
• Lead root cause analysis and corrective action using 8D and 5 Whys.
• Conduct internal and supplier audits against ISO 9001, AS9100 or IATF 16949.
• Develop control plans, inspection plans and PFMEAs with manufacturing.
• Train production staff on quality requirements.

About you

• Hands-on with root cause tools: 8D, fishbone, 5 Whys.
• Strong technical writing for reports and procedures.
• Working knowledge of ISO 9001, plus AS9100, ISO 13485 or IATF 16949 depending on site.

Schedule: Hybrid, one day remote per week after 90 days

Perks and benefits

• Employee and family assistance program.
• Extended health and dental benefits.
• Group RRSP with employer matching.
• Annual bonus.

Please include a short note on why this role interests you.

This position requires a background check.

Start: Immediately.

Demo job created on 11jobs for testing and demonstrations. It is not an actual opening at Fraser Pharmaceuticals.