Quality Consultant

Quality Consultant – Design Assurance and Compliance
(this is a direct hire position)

 

Our client is a
highly reputable Massachusetts-based QA/RA strategy and advisory firm that has
almost two decades of success and growth serving  medtech, diagnostics and bio-pharmaceutical
organizations. They are adding to their team and are seeking an experienced
individual who welcomes joining a collegial environment and enjoys delivering
top-notch service to clients. Due to their flexible telecommute work model,
this role can be based remotely. In addition, this is a direct hire position.

 

In this role, you will provide
overall Quality support and project management in areas of Design Assurance,
Quality Engineering, and Quality Management System design and implementation. You
will play a key role in strategizing and assisting medical device clients to achieve
compliance efficiently and effectively while working cross-functionally with
your team members as needed.

 

Responsibilities

 

·    
Lead and support clients in the
development and implementation of right-sized quality management systems

·    
Assist and advise clients in updates
and creation of design control documentation in preparation of upcoming regulatory
submissions and recertifications

·    
Provide quality engineering support
to clients to complement internal staffing, including participation in project
discussions, review and approval of new product development and/or production
documentation, supporting clinical builds and transfer to manufacturing

·    
Develop and/or update of quality
documentation including, but not limited to, design history files, risk
management files, Post-Market Surveillance documentation, Technical
Documentation, test plans and reports

·    
Key role in reviewing documentation
including specifications, engineering drawings, production or small-scale build
releases, non-conformances/CAPAs, test plans, protocols and reports 

·    
Lead and organize strategies for
remediation, corrective actions, and responses to questions from regulatory
submissions

·    
Manage programs with cross-functional
teams for projects of all sizes

·    
Supporting clients in on-site or
remote Notified Body, FDA and/or supplier audits and preparations for
Management Review

 

Education/Skill

·    
Bachelor’s degree in Engineering

·    
Working knowledge of key standards
and regulations including ISO 13485, 21 CFR 820, ISO 14971, MDD and MDR (IVDR
is a plus)

·    
Excellent communication,  time
management and project management capability

 

Requirements

 

·    
6+ years of hands-on experience in development
of Medical Devices in US and EU, including design assurance activities 

·    
Experience in Medical Device
manufacturing setting a plus

·    
Experience with responding to and
interacting with regulatory authorities

·    
Hands-on experience in authoring QMS
policies, procedures and forms

·    
Participation in FDA and Notified
Body Audits

·    
Experience in working with companies
of varying sizes and stages of development

·    
Able to handle multiple projects and
exercise good judgment in prioritizing tasks

·    
Adherence to program budget and cost
constraints without compromising overall project goals

·    
Demonstrated ability to work
independently and within a group setting, and to interact effectively with
various functional groups

·    
Strong communication skills (oral,
written, and interpersonal) and the ability to identify and recommend solutions
to problems

·    
High level of attention to detail,
and be proficient with Microsoft Office applications, Adobe and electronic
document management systems and templates

 

Inquiries and resumes to: Kathy Provost at kathy@agilesearchinc.com OR 978/760-2393.

For more information, please visit www.agilesearchinc.com

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