Highlights
The primary responsibility is managing the ETE IVDR/MDR product verification process for products within Roche's distributed products portfolio, including determining requirements and controls for those products and completing objective evidence of supplier evaluation and approval. Duties: Manage SCARs (Supplier Corrective Action Requests) and successfully complete them, as well as address other supplier gaps in a timely manner by tracking robust corrective action plans.
Numbers & Facts
| Location | Indianapolis, IN |
| Industry | Staffing/Employment Agencies |
| Company Size | 500 to 999 employees |
| Website | https://www.thefountaingroup.com/ |
Description
The primary responsibility is managing the ETE IVDR/MDR product verification process for products within Roche's distributed products portfolio, including determining requirements and controls for those products and completing objective evidence of supplier evaluation and approval.
Duties:
Qualifications:
Duties:
- Manage SCARs (Supplier Corrective Action Requests) and successfully complete them, as well as address other supplier gaps in a timely manner by tracking robust corrective action plans.
- Complete onboarding activities for suppliers.
- Monitor supplier performance.
- Plan and follow up on supplier audits and ensure resulting supplier actions are sufficient to resolve quality issues and are completed in a timely fashion.
- Identify and escalate issues as they arise and provide adequate solutions.
Qualifications:
- Bachelor’s / Master’s degree in Life Science, Data Science, or a related subject or equivalent experience.
- 2+ years of experience in Quality or a related function.
- Professional experience in a similar role within the medical device sector.
- Knowledge of deviation and resolution management.
- Expertise in quality systems, standards and regulations, specifically production and/or supplier development processes and standards such as ISO 13485 and ISO 27001.
About Company
The Fountain Group provides Contingent Labor, Statement-of-Work, and Contingent-to-Permanent resources to clients with an internal/external Contingent Labor Managed Service Program or Clients without a program. The Fountain Group is committed to the belief that we all share in the responsibility to conduct our businesses in a socially and environmentally responsible manner. We base this on the premise that a company is much more than the products it offers. The effect a company has on the environment, the people and the communities it serves reflects the company’s dedication to being not only a good business, but to being a good corporate citizen. The Fountain Group believes the key to servicing a client is to identify the client demand precisely. Therefore, The Fountain Group focused its efforts on building and developing a process, which can identify an exact match for our client’s needs. Our process utilizes modern technology combined with 30+ years of Talent Acquisition experience to deliver Precision resources. Financial strength is prominent among The Fountain Group’s corporate values. The future of our business will be built on the innovation, compassion, outstanding services and technology, but a solid financial foundation is required to carry us forward to meet our business goal and support our long term vision.
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