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
Location: Marlboro, MA
Employment Type: Full Time, Contract
Pay Range: 60-70hr.
Duration: 12 months
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
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.
- 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), 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
- 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
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ConneXion Systems & Engineering
490 Boston Post Road
Sudbury, MA 01776