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:
Essential Duties and Responsibilities:
• 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.
• 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.
• Bachelor’s degree or equivalent combination of education and 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.
• 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
Location: Danbury, CT
Employment Type: Full Time, Contract
Pay Range: 60-70/hr.
Duration: 3 months++
Job #: bh10159
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ConneXion Systems & Engineering
490 Boston Post Road
Sudbury, MA 01776