Quality Auditor

Greetings from Xelentra

One of Our Trichy Based Client Who are Into Manufacturing of Dental Accessories and Surgical face Masks are on the Look Out For:
Quality Manager - ISO LEAD AUDIT:
Qualification: Any Graduate

Age: Around 35 - 40 Years

Experience: 8 -10 Years (Preferably in Medical Devices - Minimum of 3 - 5 Years of Experience in Quality Audit

Location: Trichy

Number of Vacancies: 1

Package: 4.50 Lacs - 6.00 Lacs

**Principal Duties and Responsibilities**
- Plan audits by preparing and communicating audit plans.
- Execute audits through the evaluation of operations/processes, the review of documents and records, and interviews of employees for compliance.
- Communicate audit results through the preparation and publication of audit reports.
- Follow-up audit results by seeking appropriate corrective actions if deficiencies are noted.
- Track implementation of corrective actions and verify actions for effectiveness.
- Support management on tracking audit activities and administration of audit schedules.
- Support external audits including interfacing with regulatory agencies and registrars if necessary.
- Lead and support projects and initiatives to achieve Quality Systems objectives and any other regulatory objectives (e.g., QSR training, Quality Systems initiatives, etc.).

**Expected Areas of Competence**

Must be familiar with all aspects and elements of a quality system including but not limited to corrective and preventive action (CAPA), management responsibility, product realization and measurement, analysis, and improvement processes.

Must have basic knowledge of manufacturing processes; basic knowledge of CNC would be preferable.

Strong background in math, chemistry, engineering or microbiology is desirable to enable the individual to evaluate systems such as machining, sterilization, electrochemical processes, statistical process data, etc.

Demonstrated knowledge of Quality Systems Regulations, ISO requirements and guidelines, and be able to quickly develop a thorough understanding of our policies and procedures.

Must be reliable and capable of working with mínimal supervision to manage audit planning and execution, and follow-up activities.

Basic experience or knowledge on issue resolution disciplines (e.g., problem solving/decision making, root cause analysis, etc).

Must be able to manage stressful situations and to handle controversial issues.

Highly compliance oriented firmly adhere to principles of the regulations and standards.

**Education/Experience Requirements**

A Bachelor's Degree is required. A degree in a technical discipline is preferred.

At least 10 years of experience in a Quality role with at least 3 years in medical device QMS audit experience are required; prefer at least five years of quality audit experience.

Audit certifications from TUV, and Bureau Veritas or from any other reputed notified body are strongly preferred.

Medical Device regulations knowledge and experience are required.

FDA or Notified Body experience is strongly preferred.

**Roles & Responsibilities**:
The Auditor, Medical Devices will support the Business Assurance business by leading and/or participating as an assessor during all phases of a client’s management system, in accordance with the company’s accredited certification program. The Auditor is the primary interface with the client before and during the process of all auditing activities. Additionally, the Auditor will help train low-graded Auditors through witness audits, technical support, and education of both client and sales force as needed.

Audit client management system for compliance with established standards, client, and/or industry requirements, government regulations, and other relevant standards, specifically ISO 13485.

Assist clients with questions relevant to the audit and/or certification process.

Act as Lead Auditor or team member.

Coordinate audit activity with team members.

Liaison with the client regarding audit activity.

Review the client quality system and documentation

Verify and document evidence of compliance and non-compliance.

Prepare an audit report.

Review audit results with the coordinator and other assessment team members. Make presentations to clients and/or certification board concerning audit results, when required.

Assist with corrective action requirements resulting from assessments.

Participate in audit meetings.

Review audit reports and provide technical assistance to the medical team.

Support management in areas of continuous improvement.

Preferences will Be Given for Immediate Joiners

Interested and Relevant Talents Please Forward Your Updated CV to My Mail Id and Contact

Akilabalan -
+91-XXXXXXXXXX

It is an Urgent Opening Rush Your CV’s In Word Format.

Please Forward It Your Known Groups and Circles and Some One Will be benefitted

Regards

Akilabalan | Xelentra

**Job Types**: Regular / Permanent, Full-time

**Salary**: ₹500,000.00 - ₹600,000.00 per year

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