Sr. Officer - QA

We are looking for candidate expertise in Quality Assurance mainly handling below responsibilities.

If your expertise matches with the requirement kindly share your CV at swathi.p@smt.in.

Job Title

Functional Area

Key Accountabilities

Technical and QMS Documentation:

• Preparation and Review of Documents as per ISO 13485, EU-MDR, 21CFR820, Thai FDA and Indian Medical Device Rule and ensure implementation of same.
• Handling of Deviation, Non-Conformance, Change controls and CAPA.
• Handling of Post market surveillance
• Preparation of the regulatory documents (TMF/Dossiers) for regulatory submission.
• Preparation of Technical files in co-ordination with R&D Team.
• Preparation of Design file as per ISO 13485:2016, MDR and USFDA.
• Handling of Adverse event reporting to EU and other regulatory body.
• Familiar to handle Eudamed, Maude and other databases

Validations:

• Prepare and Review equipment qualification protocol and report.
• Prepare and review process validation, Analytical method validation, Software validation and cleaning validation protocol and reports.
• Ensure environment controls in clean rooms.
• Monitoring of the Processes and Process trend reporting through Minitab.
• Review and assurance of the calibration activities.
• Preparation of invitro test reports.

Audits:

• Handling of Regulatory audits, Notified Body Audits and provide audit response.
• Handling of Internal audits.
• Preparation of closure report of findings. Provide CAPA and implementation of same.
• Vendor audits and vendor development.
• Preparation and Review of the Supplier Evaluation/Assessment.
• Perform quality round at Manufacturing, Quality control, store, packaging areas.

Eligibility criteria

Min 5 years and above in Quality Department

Experience with multiple aspects of device development, including technical, regulatory, and project management required.

Demonstrated understanding of intellectual property generation and protection.

Must have the ability to interact with all levels of management and lead discussions without line authority to create alignment of senior cross-functional stakeholders.

Demonstrated ability to think strategically and deliver results is necessary.