Overview
Combination Products and Medical Devices QA Lead Jobs in Waltham, USA at CSL Behring
The Associate Director is responsible for leading Quality for Combination Products and Medical Devices (CP/MD QA) global department that supports design, development, manufacture and regulatory approval of CSL combination products, which include medical device constituent part(s) as well as the audit program to evaluate quality.
This role is accountable for the development, execution, and performance of the Global CP/MD Quality System for combination products in compliance with applicable regulations. The Quality System under the leadership of this role must define / govern quality related business processes throughout the entire combination product lifecycle, with the emphasis on the new product development activities.
The Associate Director is expected to take part in defining the overall company strategy for the combination products, as well as the strategy for the CSL Global Quality.
Reports To: Head, R&D Quality
Direct Reports: Regional Quality Engineer Combination Products and Medical Devices
RESPONSIBILITIES AND ACCOUNTABILITIES:
1. Develop, implement and manage Global CP/MD Quality System compliant with the relevant regulations, such as 21 CFR Part 4, applicable chapters of 21 CFR Part 820, MDD/MDR, as well as applicable standards (e.g. ISO 13485). The Quality System must define quality related activities throughout the entire combination product lifecycle from the product concept through commercialization, with the emphasis on the new product development activities for all CSL Behring combination products.
Processes governed by CP/MD Quality System must include but are not limited to:
Design Controls for the combination products (including risk management); CP/MD vendor management; post-market surveillance and quality reviews.
2. Direct appropriate budget and resource management within CP/MD QA by strategic assessment of workload, required planning for staffing, coordination of consultant activities as needed and on-going review of forecasted expenditures. Ensure appropriate allocation and utilization of Global CP/MD QA resources. Develop, train and mentor CP/MD Quality staff.
3. Provide QA oversight of all R&D/Technical Development projects related to combination products by:
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Developing and implementing Design Control process, as a part of CP/MD Quality System, in compliance with the requirements of 21 CFR Part 820.30, ISO 13485, MDD/MDR and other relevant regulations, as well as applicable standards (e.g. ISO 14971, IEC 62366-1). Design Control processes must incorporate appropriate quality engineering techniques such as risk analysis, statistical data analysis, sampling plan development, etc.
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Assigning resources to on-going R&D/Technical Development CP/MD projects to ensure that design development work is compliant with the applicable regulatory requirements and follows the Design Controls process. CP/MD oversight is provided for the internal design development activities, as well as custom / novel medical device development conducted by qualified vendors.
4. Ensure processes are in place for a continuous quality oversight of all active CP/MD vendors and service providers. Support Vendor Management activities applicable to CSL Behring medical device development and manufacturing vendors / service providers. These activities include the management of the vendor qualification process, conducting audits; developing and approving quality or development agreements; monitoring vendor performance.
5. Ensure consistent application of the Global CP/MD Quality System processes across the multiple global functions and manufacturing sites by:
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Developing and implementing of CP/MD QA internal auditing program
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Ensuring adequate level of training on the CP/MD QA processes across impacted functions by developing and delivering training courses (e.g. Design Controls, Risk Management, etc.)
6. Proactively monitor changing regulatory requirements for the medical devices and combination products and implement changes to the CSL Behring Quality System, as necessary to ensure compliance. Provide guidance and serve as a subject matter expert on medical device and combination product requirements in accordance with…
Title: Combination Products and Medical Devices QA Lead
Company: CSL Behring
Location: Waltham, USA
Category:
