Search Jobs

Filter
Account Executive (1)
Account Executive (PERM) (1)
Accountant I - 8829709 & 8829729 (1)
AP (1)
Applications Manager (PERM) (1)
Assembly Group Leader (1)
Associate Director HR - 8856843 (1)
Associate Scientist - 8730066 (1)
Associate Technical Lead, Software Development (Temp-To-Perm) (1)
AWS Application Architect - R1010006.01 (1)
Azure Developer - R1010039.01 (1)
Brand Marketing Manager - 8784719 (1)
CAD Temp (X2) (1)
CD Operations Engineer - 8838556 (1)
CFO (1)
Clinical Data Manager - 8884540 (1)
Coding Quality Coordinator (1)
Coding Specialist (1)
Collections Specialist (1)
Commissions Analyst (1)
Communication Senior Specialist, IT 8856935 (1)
Construction Supervisor (1)
Control System Support Specicalist (PERM) (1)
Controls Engineer (1)
Data Analyst, Business Intelligence (Temp-to-Perm) (1)
Data Architect, Insight Services (Temp-to-Perm) (1)
Data Intelligence Analyst (Temp-to-Perm) (1)
Director of Product Management, Cloud Services (PERM) (1)
Electrical Designer (1)
Electrical Engineer (PERM) (1)
Electrical Engineer III (1)
Electrical Engineering Manager (PERM) (1)
Estimator (1)
Event Coordinator - 8888194 (1)
Field Service Engineer (PERM) (1)
Field Service Technician (Temp-to-Perm) (1)
Financial Accountant (PERM) (1)
Financial Analyst - 8722454 (1)
Help Desk Support Specialist (Contract) (1)
Information Security Analyst - 8867007 (1)
Instrument & Controls Technician (1)
Integration Analyst (Temp-To-Perm) (1)
IT Support Services Manager (PERM) (1)
Java & Sharepoint Developer - R1010008.01 (1)
Leave of Absence (LOA) Analyst - 8779474 (1)
Legal Administrative Assistant (PERM) (1)
Manager, Clinical Data Management - 8882215 (1)
Manager, Clinical Training - 8866060 (1)
Manufacturing Associate (Level 1 & 2) (1)
Manufacturing Engineer (1)
Manufacturing Engineer - EE (1)
Marketing Coordinator (Temp-To-Perm) (1)
Mechanical Design Engineer X2 (1)
Mechanical Engineer (PERM) (1)
Office Services Clerk (PERM) (1)
Paralegal   (1)
Paralegal, Estate and Trust Administration (PERM) (1)
Planner (1)
Principal Network Engineer - 8518392 (1)
Principal Software Engineer, Cloud Platform & Infrastructure (PERM) (1)
Project Engineer (1)
Project Manager, Application Development (1)
QA Engineer ME (1)
QA Lead /Engineering (Temp-to-Perm) (1)
QC Inspector (1)
Retail MDM Architect - R1010010.01 (1)
Sales Account Executive (PERM) (1)
Sales Coordinator (1)
Sales Engineer (1)
Scientist - Hydraulic (PERM) (1)
Segment Marketing Programs Specialist (1)
Senior Applications Analyst (PERM) (1)
Senior Architect, Software Development (Temp-to-Perm) (1)
Senior CNC Applications Engineer (PERM) (1)
Senior Coding Analyst (1)
Senior QA Engineer (X4) (1)
Senior QA Engineer- San Diego, CA (1)
Senior Software Developer/Vision Engineer (1)
Senior Software Engineer, Sustaining (PERM) (1)
Senior Tax Analyst (PERM) (1)
Senior U/X Designer, Mobile (PERM) (1)
Senior/Principal Software Engineer (PERM) (1)
Software Engineer III - 8505459 (1)
Software Engineer IV - PLC - Leesburg,VA (1)
Software Engineer, Development Engineering (1)
Software Test Engineer - 8818660 (1)
Sourcing Specialist, Talent Acquisition   (1)
Sr Program Scheduler (1)
Sr. BIM Design Engineer (1)
Sr. Clinical Documentation Specialist - 8614667 / 8622114 (1)
Sr. Clinical Outsourcing Manager - 8814715 (1)
Sr. IT Delivery Manager (1)
Sr. Product Mgr and Regulatory Affairs Associate (1)
Sr. Software Developer (Fullstack) - 8815812 (1)
Sr. Software Test Technician (2 openings) - 8891749 (1)
Systems Test Technician - 8867609 (1)
Talent Acquisition Sourcer 8754903 (1)
Talent Development Coordinator (1)
Technical Recruiter - 8873673 (1)
Technical Sourcer - 8614623 (1)
Technical Support Engineer (PERM) (1)
Technical Team Lead (Blue Prism) - R1010017.01 (1)
Technical Writer (1)
Technical Writer - 8861096 (1)
Test Engineering Manager (PERM) (1)
Warehouse Manager (1)
Share:
« Return to Jobs
9393
Contract

Senior QA Engineer (X4)

Location: Marlborough, Massachusetts

Connexion Systems & Engineering, a Boston based IT and Engineering Solutions Company immediately seeks individuals with the following skills:

 

Date Posted: 12/12/2018

Hiring Organization: Connexion Systems & Engineering

Job Title: Senior QA Engineer

Industry: Manufacturing

Location: Marlboro, MA

Employment Type: Full Time, Contract

Pay Range:  60-70hr.

Duration: 12 months

Job#:bh9393

 

Senior QA Engineer

Participates in ensuring that the implementation, effectiveness and integrity of quality system is compliant to all applicable standards and regulations.

  • Performs gap assessments between Quality System procedures and EU Medical Device Regulation.
  • Develops quality plans for Quality System updates to changing regulations and standards.
  • Develops process flowcharts for use in creating Quality System procedures and processes.
  • Develops and implements procedures, forms and/or templates to assure compliance with Quality System Regulation, EU Medical Device Regulation and ISO 13485:2016 as well as other International regulatory requirements.
  • Initiate and complete Quality System change orders in Agile.
  • Reviews and approves quality system document changes for Quality requirements and compliance to applicable regulations.
  • Provides training on quality system requirements, as necessary.
  • Leads and/or participates in multi-departmental teams to implement Quality System updates, improvements and/or quality plans.  Identifies specific action steps, accountabilities, and timelines for completion of projects.
  • Complies with all Quality System procedures.
  • Other duties as required

Qualifications  

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  The requirements listed below are representative of the basic knowledge, skills, and/or abilities required.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  

  • Computer literate:  able to use word processing and spreadsheet programs.
  • Excellent ability to read, analyze and interpret professional journals, technical procedures and government regulations.
  • Excellent written, verbal and presentation skills.
  • Excellent interpersonal skills to interact with all levels of the company and oversight agencies, sometimes in an adversary role.

Education

  • Bachelor’s degree or equivalent combination of education and experience.

Experience

  • Seven to ten years related experience in an FDA regulated industry with at least five years recent experience in Medical Devices or equivalent combination of education and experience.

Specialized Knowledge

  • Excellent working knowledge of medical device regulations (21CFR), ISO 13485, Medical Device Directive, EU Medical Device Regulation (in particular)
  • Certified Quality Auditor/Certified Lead Auditor desirable
  • Lead Auditor experience
  • Familiarity with the corrective action and internal audit processes related to the medical device industry
  • Experience with Agile Product Lifecycle Management system a plus

Additional Details  

  • Must be able to use hands and be mobile to get around production floor, engineering labs, warehouse and dock areas
  • Vision abilities required include:  close vision, distance vision, color vision, depth perception and ability to adjust focus
  • Must be able to work independently and make decisions based on data and objective evidences
 

 

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

                 

Contact Info:                                                                                                                                             

 

ConneXion Systems & Engineering

490 Boston Post Road

Sudbury, MA 01776

jobpostings@csetalent.com