QA Manager

A career with MilliporeSigma is an ongoing journey of discovery: our 56,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. MilliporeSigma is a business of Merck KGaA, Darmstadt, Germany.

Your role:

As a member of the Burlington, ON Operations team, you are responsible for the maintenance and execution of the quality management system and supporting production of membrane chromatography products from the perspective of quality assurance.

Primary responsibilities:

• Ensure quality of products, services and suppliers in compliance with external regulations (ISO 9001) and customer quality requirements.
• Manage Quality Management System (QMS), including change control, non-conformances, corrective actions, documentation/record control, instrument calibration, supplier management, internal audits, management review, training, etc.
• Lead and manage critical quality incidents, interact with authorities with the support of MilliporeSigma quality organization
• Review and release of raw materials, finished goods, and related manufacturing documentation
• Support the initiation and review of quality improvement plans.
• Manage and report quality metrics for the site.
• Ensure site inspection readiness and host audits (e.g. customer, third party, etc.).
• Liaise with customers as point of contact for quality information including documentation requests, complaints, and audit requests.
• Liaise with greater MilliporeSigma quality organization.
• Acting as subject matter expert and delivering training to staff for all aspects of the QMS.
• All other duties as assigned

Who you are:

Experience / Qualifications

• B.S. in applied science or equivalent plus 5+ years of experience in chemistry, biology, pharmaceutical, food processing, or medical device
• Working knowledge of relevant quality standards: ISO 9001 or ISO 13485
• Experience in a quality management role in the Life Science / Biotech industry

What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

Curious? Apply and find more information at https://jobs.vibrantm.com

Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.