Quality Engineer (Medical Device) - Coyote Technical & Executive Sourcing
Windsor Locks, CT
About the Job
Quality Engineer
The Quality Engineer works with operations and product development teams to ensure compliance to the Quality Manual and other procedures from product concept through market introduction. This position assists in the design and implementation of policies and procedures for testing and evaluating the precision and accuracy of products and/or equipment.
Position Responsibilities
Provides support to ensure company compliance with FDA Quality System Regulations and ISO 9001:2008 and ISO 13485 standards.
*Actively participates in internal audits, management review and other activities covered under the Cadence Quality Manual, Policies and Procedures.
* Provides customer related quality and regulatory inquiries support.
* Actively participates in the development of the Manufacturing Supply Base including surveillance audits and Corrective Action closure.
* Compiles and writes training material and conducts training sessions on quality control activities.
* Provides quality engineering direction, analysis and recommendations for product development to successfully launch new products into active production in a timely and cost effective manner.
* Develops and initiates standard methods for inspection, testing, and evaluation, utilizing knowledge in related engineering fields.
* Devises sampling procedures and designs and develops forms and instructions for recording, evaluating, and reporting quality and reliability data.
* Performs measurement system analyses to evaluate test and inspection equipment.
* Monitors and directs engineering group on calibration requirements and implementation of systems to support equipment calibration.
* Monitors and directs quality group on certificate of compliance requirements and improvement or implementation of systems to support certificate creation.
* Assists workers engaged in measuring, testing, and tabulating data concerning quality and reliability.
*Actively participates in internal audits, management review and other activities covered under the Cadence Quality Manual, Policies and Procedures.
* Provides customer related quality and regulatory inquiries support.
* Actively participates in the development of the Manufacturing Supply Base including surveillance audits and Corrective Action closure.
* Compiles and writes training material and conducts training sessions on quality control activities.
* Provides quality engineering direction, analysis and recommendations for product development to successfully launch new products into active production in a timely and cost effective manner.
* Develops and initiates standard methods for inspection, testing, and evaluation, utilizing knowledge in related engineering fields.
* Devises sampling procedures and designs and develops forms and instructions for recording, evaluating, and reporting quality and reliability data.
* Performs measurement system analyses to evaluate test and inspection equipment.
* Monitors and directs engineering group on calibration requirements and implementation of systems to support equipment calibration.
* Monitors and directs quality group on certificate of compliance requirements and improvement or implementation of systems to support certificate creation.
* Assists workers engaged in measuring, testing, and tabulating data concerning quality and reliability.
Quality Engineering Project Duties
* Leads or participates in the implementation of continuous improvement projects or acts as subject matter expert for SPC, FMEA, DOE and process validation.
* Provides Project Management support as needed.
* Other duties as assigned.
* Provides Project Management support as needed.
* Other duties as assigned.
Education/Experience
Bachelor’s Degree in Engineering or Quality related field desired. At least 2-3 years experience in the Medical Device or other highly regulated industry is preferred.
Other Qualifications
Experience with FDA, ISO 9001:2008, and ISO 13485 is a strong plus.
* Experience with regulatory requirements and ISO Certification inspections
* Knowledge in areas which include, but are not limited to: Statistics, SPC, Geometric Dimensioning/Tolerancing; Sampling, Design of Experiments, etc.
* Ability to analyze, understand and effectively communicate technical data.
* Must possess excellent verbal & written communication skills, which include but are not limited to presentation, organizational and management skills.
* Experience with regulatory requirements and ISO Certification inspections
* Knowledge in areas which include, but are not limited to: Statistics, SPC, Geometric Dimensioning/Tolerancing; Sampling, Design of Experiments, etc.
* Ability to analyze, understand and effectively communicate technical data.
* Must possess excellent verbal & written communication skills, which include but are not limited to presentation, organizational and management skills.
Certifications
Quality Engineering Certification (CQE) preferred or equivalent
* Six Sigma, Lean Manufacturing, and/or other manufacturing related certifications a plus
* Six Sigma, Lean Manufacturing, and/or other manufacturing related certifications a plus
No sponsorship visa (H1-B, etc) candidates at this time, sorry.
Qualified candidates must submit their resume in Microsoft Word format along with at least three professional references to:
COYOTE TECHNICAL & EXECUTIVE SOURCING
Phil Montoya
Director of Sourcing
Quality Engineer - Medical Device - Granby, CT
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Source : Coyote Technical & Executive Sourcing