About this role
- Quality Assurance in the processes related to the storage and distribution of materials, sub-assemblies, and completed products and their supply chain, including compliance to regulatory requirements and/or procedures for regulated products/businesses;
- The job will include the trend analysis and monitoring of processes, the remediation of field actions, and the development and improvement of Quality systems;
- Providing support for regulatory actions and product containment activities (e.g., DPIAs, product holds, recalls, etc.);
- Providing support of business operations ensuring on time completion of project deliverables, correcting issues delaying completion and reporting on QMS status of projects;
- Providing support of operations during internal and external audit/inspections;
- Performing other duties as required.
- Ability to communicate effectively both orally and in writing and to establish and maintain cooperative working relationships with persons contacted in the course of performing assigned duties including Company management and outside business associates;
- Bachelor's degree in a Technical, Science, or Engineering discipline;
- 1+ years’ experience in quality assurance in medical device or other highly regulated industry;
- Familiarity with appropriate global medical device regulations, requirements, and standards, such as ISO 13485:2016, 21 CFR Parts 803, 806, and 820. Familiarity with ISO14971, European Medical Device Directive (93/42/EEC), Canadian Medical Devices Regulation (SOR/98-282), and Japanese MHLW Ordinance 169 desired but not required;
- ASQ Certification as CQE or DfSS/DMAIC Green (or other recognized Accreditation bodies) is desired.
What we offer
Why work with Brunel? We are proud to offer exciting career opportunities from over 100 offices globally in 42 countries. Advancing your career takes time and effort – let us match you to your ideal position.
Brunel has a reputation for working with some of the best in the business. That’s what we continually strive for. Over 40 years, we’ve created a global network of interesting clients and talented individuals working together through a vast array of services.
- Vacancy number: PUB245678
- Location: Rancho Cordova
- Market: Life Sciences & Health Care
- hours per week: 40
- Branch: Pharmaceutical
- Education level: Academic Bachelor
- Area of Expertise: Regulatory
- Closing date: Sunday, February 2, 2020
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