Search Jobs

Filter
Regulatory Affairs Specialist (2)
Senior Systems Engineer (PERM) (2)
Support Technician (PERM) (2)
(2) Sales Order-Customer Support Specialists (1)
5+ Embedded Software Engineers (1)
AIX Team Lead - R1010211.01 (1)
AR Collections Specialist (1)
AR/AP Clerk (1)
Art Director - 9366346 (1)
Assembly Supervisor (PERM) (1)
Associate Director of Planning (PERM) (1)
Associate II, Manufacturing, 2nd shift (1)
Associate Technical Lead, Development Engineering (Temp-to-Perm) (1)
Associate Technical Lead, Software Development (Temp-To-Perm) (1)
Business Analyst, Development Engineering (Temp-to-Perm) (1)
Business Systems Analyst - 9056306 (1)
Buyer/Planner (1)
Coding Quality Coordinator (1)
Coding Specialist (1)
Communications Specialist I - 9357774 (1)
Compliance Engineer (1)
Contract Recruiter (1)
Contract Recruiter - OneSource - Naperville, IL - 318 (1)
Contracts Paralegal - 9025308 (1)
Controller (PERM) (1)
Controls Engineer (1)
Copier Service Technician Position (PERM) (1)
Credit and Collections (1)
Credit and Collections Analyst - 9306239 (1)
Data Analyst, Business Intelligence (Temp-to-Perm) (1)
Data Architect, Insight Services (Temp-to-Perm) (1)
Data Intelligence Analyst (Temp-to-Perm) (1)
Desktop Analyst (PERM) (1)
Digital Marketing Consultant Director (PERM) (1)
Digital Marketing Manager (1)
Director of Revenue Worldwide 9285153 (1)
DMS Administrator (PERM) (1)
Electrical Design Engineer (X3) (1)
Electrical Engineer (1)
Environmental/Civil Engineer (1)
Facilities Manager/Engineer (1)
Financial Analyst - 9386241 (1)
Front End Developer (1)
Full Stack Engineer (1)
Global Partner Management Administrator - 9285194 (1)
Help Desk Support Specialist (CONTRACT) (1)
HR Learning & Development Project Coordinator - 8795069 (1)
Information Security Analyst (PERM) (1)
Inside Sales Rep (1)
Instrument & Controls Technician (1)
Integration Analyst (Temp-To-Perm) (1)
iPro Software Engineer in Test - 9278118 (1)
Java Developer (7 openings) - R1010163.01 (1)
Machinist II (1)
Manager, Provider Enrollment (PERM) (1)
Manufacturing Controller (1)
Manufacturing Engineer (PERM) (1)
Marketing Assistant (PERM) (1)
Marketing Assistant - Telemarketing (1)
MARKETING Recruiter - 9391085 (1)
Mechanical Design Engineer (Faxitron) (1)
Mechanical Engineer II (PERM) (1)
Network Engineer Infrastructure (Temp-to-Perm) (1)
Office 365 / Azure Sr. Support Representative (PERM) (1)
Patent Paralegal/ Senior Patent Administrator   (1)
Planner (1)
Primavera P6 Risk Management Consultant - R1010237.01 (1)
Principal UI Software Engineer, Cloud Platform & Infrastructure (PERM) (1)
Product Management Consultant - 9373041 (1)
Program Manager (1)
Quality Control Engineer (1)
Quality Engineer (Danbury, CT)  (1)
Quality Engineer (EU Project)  (1)
Quality Engineer (San Diego, CA) (1)
Quality Engineering Manager I (PERM) (1)
Quality Inspector (1)
Reliability Engineer (1)
Report Developer II, Business Intelligence (Temp-to-Perm) (1)
Revenue Analyst III - 9361994 (1)
Sales Coordinator (1)
Sales Manager (PERM) (1)
Security Solutions Engineer - Post Sales (PERM) (1)
Senior A / V Specialist (PERM) (1)
Senior Account Executive (1)
Senior Applications Analyst (PERM) (1)
Senior Applications Specialist, Billing Applications (Temp-to-Perm) (1)
Senior Architect, Software Development (Temp-to-Perm) (1)
Senior Coding Analyst (1)
Senior Electrician (1)
Senior Financial Analyst (1)
Senior Financial Analyst - 9408830 (1)
Senior Financial Analyst (PERM) (1)
Senior Mobile Engineer (1)
Senior Product Manager - Authentication Management (PERM) (1)
Senior QA Engineer (Risk Management) (1)
Senior QA Engineer (Temp-to-Perm) (1)
Senior Recruiter - Corporate functions - G&A -9367826 (1)
Senior Scrum Master (PERM) (1)
Senior Software Developer - Pittsburgh, PA - 357 (1)
Software Architect (PERM) (1)
Software Engineer II - 9256269 (1)
Software Engineer in Test - 9379451 (1)
Software Engineer, Development Engineering (1)
Software Engineer, Distributed Systems "Cloud" (PERM) (1)
Software Test Engineer 1 - 9294363 (1)
SQL Server BI report Developer (1)
Sr. BIM Design Engineer (1)
Sr. Mgr of Inside Sales (1)
Sr. Rail Analyst - R1010220.01 (1)
Sr. Remote Support Analyst (PERM) (1)
Staff Accountant (CONTRACT - Roughly Thru End of Year) (1)
Supply Chain Manager (1)
Systems Architect (PERM) (1)
Systems Test Technician - 9281803 (1)
Talent Acquisition Manager (1)
Technical Lead - Sensing Systems (1)
Technical Project Manager - 9293494 (1)
Technical Support - 9397769 (1)
User Interface Developer IV - 8889897 (1)
Share:
« Return to Jobs
10159
Contract

Quality Engineer (EU Project) 

Location: Danbury, Connecticut

Connexion Systems and Engineering, your Boston staffing experts, would like to provide you with details about this new opportunity as we are seeking individuals with the following skills:

 

Quality Engineer  

Essential Duties and Responsibilities:

Quality Systems

• 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, MDSAP, 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. 

Qualifications

• 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), MDSAP, 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

 

Date Posted: 7/2/2019

Hiring Organization: Connexion Systems & Engineering

Job Title: Quality Engineer

Industry: IT/Engineering

Location: Danbury, CT  

Employment Type: Full Time, Contract

Pay Range:  60-70/hr.

Duration: 3 months++

Job #: bh10159

 

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!

ConneXion Systems & Engineering

490 Boston Post Road

Sudbury, MA 01776