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Quality Engineer

Marlborough , MA 01532

Posted: 04/05/2022 Industry: Engineering and Technical Job Number: 14201

Job Description

Connexion’s mission is to provide "best in class" services to job seekers. We strive to achieve excellence in job placement, staffing, and recruiting services while treating candidates with the professionalism and respect they deserve.

 

Title: Quality Engineer

Hiring Organization: Connexion Systems & Engineering

Compensation, Benefits, and Employment Type

Duration: Perm   

Pay rate: $75k

Job Location: Marlborough, MA

 

Job#: bh 14201

 



Quality Engineer

Job Description

Responsible for the development and administration of a Quality System compliant to FDA and ISO requirements, including the utilization of optimal, cost-effective lean manufacturing processes and methods for new and existing projects including inspection, test and label control operations. Working with internal and external customers supports, quality and continuous improvement using appropriate tools, and project leadership.

Quality Engineer Expectations:

  • Supports internal audit program as necessary.
  • Supports customer complaint (CC) and RMA system per procedures. Performs investigations, supports the determination of the disposition of returned goods, determines re-inspection requirements, determines corrective and preventive actions (CAPA), issues complaint reports, supports completion of customer CAPAs, and approves to close. Looks for trends to determine actions to decrease the number of CCs
  • Maintains a Non-Conforming (NC) system per procedures. Performs investigations, participates in MRB (Material Review Board) activities, supports determination of the disposition, determines re-inspection requirement, supports determination of corrections/corrective actions and approves to close. Looks for trends to decrease number of NCs and provide feedback to management
  • Maintains corrective and preventive action (CAPA) system per procedures. Initiates and performs root cause analysis. Uses statistical and capability analysis to solve problems. Implements and verifies CAPAs
  • Performs trend analysis of CAPA, NCM, Complaint/Customer Feedback, Risk Management activities, Audits, etc. and presents periodic reports for management review. Assesses Design and any associated activities for manufacturability.
  • Adheres to the company’s Quality System (QS), writes and approves QS documents
  • Authors and executes Quality Plans for Quality Management Systems and Organizational Objectives projects.
  • Support Engineering, Manufacturing, and Inspection personnel in design, methods, tooling, validations, and other areas related to the control of product quality.
  • Communicates with customers on complaints, process changes, clarification of specifications, completing customer documents, and other projects as needed
  • Conducts studies including Gauge R&R’s to develop inspection methods and test equipment. Creates measurement system programs, when necessary.
  • Establishes inspections and sampling procedures to ensure the control of quality at the most economical costs
  • Creates, reviews and approves Equipment Qualifications, Process, Cleaning, and Software Validation, pFMEA and other documentation as necessary.
  • Participates in customer and ISO audits.

Quality Engineer Qualifications:

Required:

  • 4-year degree in quality, engineering, or any related field

Desired:

  • 2+ years in a manufacturing environment in a technical support role
  • ASQ Certified Quality Engineer
  • Formal Six Sigma Yellow/ Green belt training

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran, disability, or any other status protected by state or federal law.

 

Please use the apply button to submit your resume for consideration. A Connexion Representative will contact you immediately.

 

When responding to this job posting you MUST include the Job# and Job Title in your subject line.

 

If you are active in a job search but this job is not for you, please reach out to jobpostings@csetalent.com. We would be glad to help you find the perfect job!

 

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Meet Your Recruiter

Emily Donahue
Regional Recruiting Manager

  • Directthe recruitment efforts for both the Quincy, MA and Providence, RI branches. 
  • Manages a distributed team of recruiting leads, individual contributor recruiters and account managers. 
  • Responsible for leading the fulfillment and execution of sourcing, recruiting, sales and business development practices across the region. 
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