Hi Friends,

Hope you are doing great,

I have an urgent requirement from one of my esteem client, I will
appreciate if you can have an eye on the below requirement and send me your
consultant updated profile ASAP.



*Job Title: Sr. Quality Engineer*

*Location: Chelmsford, MA / Morrisville, NC / Wyomissing, PA*

*Duration: Long Term Contract*



*Job Description: *

·         Good experience in performing Installation Qualification (IQ),
Operation Qualification (OQ), and Process Qualification (PQ) validation
protocols.  Provides statistacally valid sampling plans when required.

•     Good experience in closure of both the CAPA and Non-Conformance
quality systems. Track internal quality issues and report on corrective
action progress, including performaing failure investigation and making
recommendations for corrective actions.

•    Support and evaluate current test and inspection methods to identify
areas for improvement, efficiency and cost reductions.

•    Partners with affiliated disciplines, (ie Regulatory Affairs, Quality
Engineering, New Product Development, Operations, Supplier Management)
through the Product Design and Development Process to assure that adequate
design controls and/or procedures are complied with and met.

•    Works closely with purchasing and product development with onboarding
and maintaining supplier files during the development process as well as
routine maintenance of all supplier files.

•    Implements yearly objectives that support overall strategic plan.

•    Ensure full compliance with quality and regulatory requirements.

•    Proficient with Microsoft Office, including Word, Excel, Powerpoint
and Outlook (ie database development, statistical software and analysis,
simulation, word processing for report generation, etc)

•    Outstanding written and verbal communication skills including the
ability to effectively communicate with a broad spectrum of people with
varying backgrounds, education and experience.

•    Ability to use and apply statistical skills, such as DOE, SPC,
Reliability, Gage R&R.



*Education / Experience Requirements:*

•    Bachelors Degree required. Prefer focus in engineering, life science
or related discipline.

•    5 years minimum related quality experience in a manufacturing
environment. Experience in the medical device industry preferred.
Experience in the Design and Development process preferred.

•    Broad experience in manufacturing operations, including new product
development and implementation, process qualification, cost reduction and
quality engineering.

•    Prefessional Certification, ie 6 Sigma black belt, ASQ – CQA, CQE
and/or CRE; RAB preferred.

•    Strong regulatory, cGMP, QSR, ISO knowledge base..



Thanks & Regards,

Sai Kiran Nandrolu

Sr. Recruiter

W: (972) 393-2255

E:  [email protected]

A:  1701 Legacy Dr, Suite#1000, Frisco, Texas - 75034

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