Quality assurance and regulatory affairs

Hello Connections,

We have immediate openings for the following positions.

Open Positions in theQARA-DQARole

Greetings from Tekaccel!

Job Title:QARA-DQA

Experience: 5+ years

Location:Gurgaon

Work mode: WFO

NP: 0-30 Days

Hire type: Full-time

Key Responsibilities:

Be a part of the sustaining project team and work in the design quality engineering across the entire product cycle.

Ensure appropriate project/sustaining quality deliverables are created and properly executed (e.g., project design & development plan, risk management plan, hazard analysis, use and design FMEA, field assessment plan, and software validation plan if applicable).

Working on product DHF, design input, design output, product risk management, usability, verification, and validation efforts (if required) for commercial products.

Ensure adherence to the quality systems and design assurance SOPs and the customer's PLCP.

Provide quality and regulatory compliance guidance as needed to product development or design change project teams to assure country-specific compliance with the laws and regulations of the targeted market for distribution.

Lead in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements.

In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance with the Quality Policy and all other documented quality processes and procedures.

For those individuals who supervise others, the following statements are applicable:

Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the Customer's Quality Policy.

Job Scope and Leveling Guidelines.

Functional Knowledge.

Requires expanded conceptual, technical, and/or functional knowledge in the medical device design quality domain.

Plans and organizes non-routine tasks with approval. Initiates or maintains work schedule and priorities. Plans and organizes project assignments and maintains project schedules.

Uses and exercises judgment to solve problems in straightforward situations and determine appropriate action/solutions.

Works under general direction from more senior-level roles/managers.

Candidate should have 5+ years of experience.

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Tekaccel Software Services India