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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