*Please reply on anu...@technocraftsol.com <anu...@technocraftsol.com>*

*Position: Validation Engineer*

*Location: Rochester, NY*

*Duration: 12 months*

*Rate: $38/hr. (no flexibility – this is the set range)*

*Education: Bachelor's Degree                     *



*Job Description & Requirements*



*Qualifications:*



• A minimum of a BA/BS in Life Sciences, Engineering, Physical Science or a
related discipline is required; an MA/MS in Life Sciences, Engineering, or
Physical Science is preferred.

• Must have at least 5 years of related experience in Medical Device
quality system management, including experience in working under Design
Control.

• ASQ certification a plus.

• Computer skills/data analysis skills (Word, Excel, PowerPoint, Minitab,
Visio, MS Project) is required.

• Effective oral & written communication skills are required.



*Responsibilities: *



• Works independently and sets an example in ensuring compliance to Design
Controls and other Quality System requirements to assigned project(s).

• Utilizes Six Sigma/Process Excellence to solve complex problems and
develop optimal product performance.

• Partners with R&D, Operations, Quality, Regulatory and Compliance,
suppliers and other groups to ensure effective product development and
transfer of knowledge.

• Provides technical input as appropriate.

• Ensures effective implementation of risk management requirements to
prevent unanticipated failure modes and quality issues.

• Provides input as needed to regulatory inspections.

• Executes Failure Investigations and corrections of design related quality
issues.

• Utilizes advanced Quality Engineering tools (data analysis, statistics,
sampling plans, etc.) to ensure effective product development.

• Participates in post-product launch failure investigations.

• Provides guidance and leadership to junior members of the team..

• Suppliers/External Manufacturers: Directly or indirectly support design
change control activities.

• Review and approve plans/protocols and reports,
deviations/nonconformances, and document changes through the change control
processes for accuracy and completeness.

• Proactively identifies issues, troubleshoots issues, and escalates
concerns as appropriate. Adheres to strict procedural and quality standards
including thorough and accurate documentation, testing protocols.



*Thanks and Regards,*

*Anurag*

*IT Recruiter*

*Email -* *anu...@technocraftsol.com <anu...@technocraftsol.com>*

*Contact: **614-664-7649*

*Yahoo ID - **anuragtechnocraft*

*Gmail ID – **anurag.technocr...@gmail.com <anurag.technocr...@gmail.com>*

*LinkedIn: **www.linkedin.com/home?trk=nav_responsive_tab_home
<http://www.linkedin.com/home?trk=nav_responsive_tab_home>*

*Website*: www.technocraftsol.com

*Note: Technocraft Solutions LLC works with Direct Client’s and Preferred
Vendors Nationwide.*

*Your confirmation would means that you understand the level of Technocraft
Solutions LLC association for the mentioned project and will not approach
Technocraft Solutions LLC Client directly**.*

*Note* : If you have received this mail in error or prefer not to receive
such emails in the future, please reply with "REMOVE" in the subject line
and the email id(s) to be removed to my official id (
anu...@technocraftsol.com). All removal requests will be honored ASAP. We
sincerely apologize for any inconvenience caused.

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