Quality Assurance Company

6 days ago

Hyderabad, India Seneca Sense Technologies Full time

**Job description**

**Quality Assurance Company**

**Seneca Sense Technologies.** Currently looking for a **Quality Assurance Company** in order to join our team as a Full-time at a very flexible and fast-growing company. Seneca Sense Technologies. Value all team members and are always looking for fresh perspective and insight.

**Overall Job Summary**:
To manage quality activities and implement a quality management system (QMS) to support the development and commercialization of our product(s) in compliance with ISO 13485:2016, ISO 14971:2019, 21 CFR 820 and applicable regulations in Canada, the United States, and Europe.

**Requirement**:

- Minimum three years of experience in Quality Assurance, including experience with a Medical Device.
- Knowledge of applicable regulatory requirements (Health Canada and FDA), ISO 13485:2016, 21 CFR Part 820, ISO 14971:2019, IEC 62304:2006 + 2015, and SOR/98-282
- Ability to understand the technical aspects of the company’s product(s).
- Effective planning and organizational skills.
- Structured, rigorous.
- Problem-solving skills.
- Proven record of successful completion of tasks with mínimal supervision.
- Superior interpersonal, communication and leadership skills.

**Duties will include, but are not limited to**:

- Contribute to the establishment and revision of SOP’s within the company.
- Supervise and coordinate all QMS activities with internal and external stakeholders.
- Ensure that processes needed for the quality management systems are documented, adequately implemented and that risk-based approaches to the QMS processes are maintained.
- Provide training to new and existing employees on QMS and regulations.
- Support the design and development and production teams to ensure compliance with applicable medical devices regulations and requirements, including risk management processes (ISO 14971) and software lifecycle processes (IEC 62304).
- Ensure maintenance of the Design History File (DHF) and Device Master Record (DMR).
- Ensure the development, maintenance, and analysis of key performance indicators and trends, propose and follow-up on initiatives to improve the organization's performance.
- Plan, organize, and execute quality management reviews.
- Plan and manage internal and external audits and conduct supplier audits and qualifications as applicable.

**Job Types**:

- Full-time, Permanent

**Schedule**:

- Monday to Friday

**Job Type**: Contractual / Temporary
Contract length: 12 months

Schedule:

- Day shift
- Monday to Friday

**Experience**:

- total work: 1 year (preferred)

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