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Jubilant DraxImage inc.: Specialist Quality, Medical Devices

Jubilant DraxImage inc.

This is a Full-time position in Montreal, QC posted June 7, 2021.

Jubilant DraxImage, a subsidiary of Jubilant Pharma Holdings Inc, is currently recruiting for a Specialist Quality, Medical Devices to join our growing team What can we offer?

A culture that values opportunity for professional growth and development, highly competitive base pay, comprehensive medical, dental and disability benefits programs, group retirement savings program, health and wellness programs.

Jubilant DraxImage Inc.

is a rapidly growing company with offices in Kirkland, QC and Yardley, PA.

A global leader in the development of radiopharmaceuticals and state-of-the-art technologies, we are continuously seeking high caliber professionals to join our team.

Jubilant DraxImage is a proud member of the Jubilant Pharma family.

For more information, visit www.Draximage.Com We will, with the utmost care for the environment and society, continue to enhance value for our customers and stakeholders by providing innovative products and economically efficient solutions’ through growth, cost effectiveness and wise investment of resources.

If you’re up for a rewarding challenge, we invite you to take the first step and apply today Jubilant Pharma Holdings Inc and all our subsidiaries proudly embraces diversity in our workforce.

Our goal is to have a workforce as diverse as the patients and clients we serve.

We have an inclusive environment where our employees can thrive and where our differences are welcomed.

By welcoming our differences, we create products that are beneficial for our patients, clients, and overall human health.

Summary To ensure JDI Medical Device products maintain a compliant quality system to current Medical Device Regulations (ISO 13485, MDD, EU MDR, FDA CFR Part 820 & CMDCAS). To ensure that activities related to medical device development, manufacture, distribution, CAPA, complaint handling, design changes and regulatory filings are in full compliance with regulations, sound scientific practice, Current Good Manufacturing Practices, company policies and standard operating procedures.

Responsabilities Implements quality processes and maintains certification program as per ISO 13485 / FDA CFR Part 820, as well as, implement continuous improvement solutions.

Subject Matter Expert on regulations, norms and standards (ISO, ASTM, ICH, USP, Ph.

Eur., EU MDR, etc.) relating to medical devices.

Assist in site transition to EU MDR regulations.

Mentors and provides training to colleagues on medical devices regulations and requirements to ensure compliance to ISO 13485, EU MDR, 21 CFR 820 and CMDCAS.

Supports Medical Device Development activities and projects; acts as the liaison to Quality to ensure continuous Compliance.

Supports suppliers in relation to medical devices regulations and requirements to ensure compliance to ISO 13485 and 21 CFR 820.

Acts as essential contact during Medical Device Inspections.

Supports in Internal Audits related to Medical Device quality system processes.

May support in External Audits of Medical Device CMOs and suppliers to ensure compliance to applicable standards.

Defines strategies and objectives for quality and regulatory compliance related activities.

Monitors the pertinent regulations and standards issued by Canadian, American and European regulatory authorities, as well as by various certification organizations, for all medical device products.

Updates the team on changes.

Involved in change control process for approved Medical Device products.

Supports the CAPA investigation process, collaborating with owners to ensure effective root cause analysis and the development of scientifically sound and innovative, long-term solutions.

Supports complaint investigation process for medical devices.

Tracks effectiveness of corrective action plans and compliance of improvement initiatives.

Ensures accurate quality project schedules are maintained and communicated to both internal and external stakeholders.

Supports the development, commercialization, launch and life-cycle management of medical devices through participating as the Quality representative in product/project teams.

Participates in successful and smooth design transfer from development to commercial production and quality for new medical device products.

Supports the implementation and maintenance of service cloud for medical devices, through participating as the Quality representative to ensure commercial goals are achieved in compliance with JDI quality and Pharmacovigilance procedures.

Performs others duties as assigned by Management.

BSc.

in Science or Engineering in a related field ISO 13485, EU MDR Minimum of 8 years of Quality experience supporting Medical Device Manufacturing Operations Thorough understanding of Good Manufacturing Practices, Quality Systems, Regulatory Requirements, Validation Principles and Manufacturing Methods in a Medical Device regulated environment FDA CFR 820 / ISO 13485 / EU MDR expertise is required Good Knowledge of ISO 14971 “Application of risk management to medical devices” Bilingual with strong English writing and communication skills Leadership ability, self-motivated, organized with attention to detail