Quality Management Associate

3 weeks ago

Mississauga, Canada BD Full time

**Job Description Summary**: SUMMARY

The Quality Management Associate (QMA) has the responsibility and authority for assisting Quality Management in the routine oversight and operation of the Quality related matters within the Distribution Center (DC). This position is also responsible for ensuring that BD - Canada complies with applicable regulations including Canadian Medical Devices Regulations and Good Manufacturing Practices, and BD quality management and compliance directives.

We are** the makers of possible**

BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a **maker of possible** with us.

Reports To: Director, Quality Management

Location: BD Canada, Mississauga

Employee Type**:CONTRACT POSITION October 1, 2023 - October 1, 2024**

**SUMMARY**

The Quality Management Associate (QMA) has the responsibility and authority for assisting Quality Management in the routine oversight and operation of the Quality related matters within the Distribution Center (DC). This position is also responsible for ensuring that BD - Canada complies with applicable regulations including Canadian Medical Devices Regulations and Good Manufacturing Practices, and BD quality management and compliance directives.

**ESSENTIAL DUTIES AND RESPONSIBILITIES**
- Responsibilities include support to ensure the DC maintains a robust, effective Quality Management System and complies with applicable BD procedures and the Quality Agreement between BD and 3PL. The role will provide support to Quality Management Process Lead and Quality oversight at the DC.
- Assist in review, roll out, and oversight of BD SOPs and the Review c2c reporting and ensure 3PL compliance to bd procedures.
- Perform BD Quality functions related to product disposition; including but not limited to conducting product local hold, global holds, and product release functions within BD electronic systems.
- Perform product activation and create the inspection plans within ERP systems
- Collaborate with DC 3PL on inventory damages and provide information to the source plant, vendor, or carrier to determine root cause and drive solutions to keep damage to future shipments to a minimum.
- From a BD Quality perspective, support 3PL in identification of damaged product when unclear and/or escalation if required for final disposition. Evaluate and provide direction to the DC with inventory that has suspected damage and is at risk of being scrapped.
- In support of Quality Management Process Lead, oversee inspections, e.g. Drugs, NHPs, Temperature Sensitive Material, CSA, Hold/Recalls, and drug retention sample management.
- Operates independently or in support of Quality Management Process Lead in facilitation of Annual Product Review, DC GMP drug activities, and support customer inquiries for product stability and disposition.
- Oversee 3PL Perform incoming inspections and provide final product disposition on incoming or returned product.
- Provide guidance and input of 3PL initiated Nonconformances and CAPAs as needed.
- Support the investigation of applicable BD Nonconformance and CAPAs sourced from the DC, temperature excursions, or BD plants. Provide support in SCAR creation and investigation.
- Other DC Quality duties as assigned, including but not limited to special projects, support of BD and 3PL Regulatory inspections, support of BD internal audits, support of 3PL audits by Health Canada and by BD.

**QUALIFICATIONS**
- Excellent verbal and written communication skills
- Customer Focus - dedicated to meeting needs and expectations of internal and external customers
- Effective and timely decision making, problem solving and trouble shooting skills
- Strong organization and time management skills to handle multiple activities
- Drive for Results - can be counted on to achieve goals successfully
- Continuous Versatile Learning - has the job, functional and technical knowledge and skills to do the job at a high level of accomplishment
- Sharing of Best Practices Across DC Network / Manufacturing Sites

**Education and Exerience**:

- Bachelor of Science degree in life sciences or related discipline preferred
- 2-3 years quality experience in medical device and/or pharmaceutical industry
- Experience in Supply Chain and/or Distribution Center Operations preferred
- Experience in SAP or JDE environment preferred
- Knowledge and experience with Canadian Medical Devices Regulations and Good Manufacturin

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