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Job Opportunity :: Quality Engineer(Medical Device Industry) :: Plymouth, MN (Onsite) at Plymouth, Michigan, USA
Email: [email protected]
From:

Brajesh Roy,

Scalable Systems

[email protected]

Reply to:   [email protected]

Hi,

Greetings of the day!

I have an urgent requirement below, please go through JD and let me know if you are comfortable or have any profile. Kindly revert me back with your updated resume as well.

Job Title:
Quality Engineer(Medical Device Industry)

Location:
Plymouth, MN (Onsite)

Duration:
Contract to Hire

Client: TCS

Key Responsibilities:

Knowledge of Medical procedure and corresponding Medical Equipment

Good experience in CAPA execution, CAPA write-up

Good experience in Test Method Validation (TMV)

Good experience in Process Validation.

Knowledge of Medical Equipment manufacturing processes

Knowledge on Quality Management and its tools & techniques

Knowledge about FDA, ISO 13485, ISO 14971 and compliance regulations

Knowledge on NC, Audit processes

Knowledge in Statistic, Risk Management and Design control

Must possess good communication skills (verbal and written), familiar with project management methodology, problem solving, and presentation skills

A minimum with 5+ years of related experience Quality Management in Medical Device Industry.

Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, the duties and responsibilities for this position are:

Working with other functional groups, including R&D and Operations in support of new product development, engineering projects, quality assurance activities, and lifecycle management.

Utilizing Quality Engineering tools/processes in development and implementation of practices for the effective and efficient development.

Non-Conformance Report (NCR) process for Sterilmed business unit.

Develop and establish effective quality control and support associated risk management plans, AFMEA, DFMEA and PFMEA.

Write, review and/or approve process and product validation protocols and reports, engineering change orders.

Use statistical tools to analyze data, make acceptance decisions, and improve process capability, Design Controls, Design of Experiments

Technical problem solving, failure analysis, and root cause determination.

Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.

Strong communication skills. Candidates must be highly proficient in reading, writing, and speaking English language.A Minimum Bachelors Degree in Engineering, Science

Thanks You,

Brajesh Roy

Email:

[email protected]

Keywords: rlang golang Minnesota North Carolina
Job Opportunity :: Quality Engineer(Medical Device Industry) :: Plymouth, MN (Onsite)
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Wed Jun 26 23:07:00 UTC 2024

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