Senior Quality Assurance - South East, United Kingdom - On Target Recruitment Ltd

On Target Recruitment Ltd

Verified Company

South East, United Kingdom

2 weeks ago

Posted by:

Tom O´Connor

beBee Recruiter

Description

Reference

OTRDG121023A
Products
Surgical Implantables'/Spinal
Customers
Internal Stakeholders
Location
South East
Package

- £45k-£55k + 10% Bonus, Company Car, Private Healthcare, Dental Plan, Holidays, All tools needed to do the job, Ongoing training and support from the business
_

The Company:
_

Global organisation
Industry leading products
Year on Year Growth

_The Role of the Senior Quality Assurance &

Regulatory Specialist:
_

Our client is one of the market leaders in spinal implants.
They are now looking for a Senior Quality Assurance & Regulatory Specialist to focus on their distribution model.
You will deal with the initial compliance and ongoing preparation, testing and monitoring of product and service conformance to established quality assurance processes and standards.
You will evaluate internal controls, communications, risk assessments and maintenance of documentation as related to compliance with internal and external safety, quality, and regulatory standards.
Look to identify risks and evaluates deficiencies while working with internal departments to appropriately remedy them.
Provide internal training on quality assurance requirements, processes, and procedures.
You will also perform audits and risk assessments as needed.
Implement and define procedure and processes
Reviews and distributes standardized reporting mechanisms to support Quality Assurance and Regulatory Affairs teams, including query generation, charts and analysis.
Provide data analyses in support of internal and external customers as needed, including data related to, site visits and regulatory agency correspondence.
Coordinates investigations, identifies adverse trends, and supports the resolution of complaints and product performance issues.
Focuses on product and process improvements to ensure quality system activities remain compliant.

_Benefits of the Senior Quality Assurance & Regulatory Specialist _
- £45k-£55k

10% Annual Bonus
Private Healthcare
25 days annual leave
All tools needed to do the job
Ongoing training and support from the business

_The Ideal Person for the Senior Quality Assurance & Regulatory Specialist _

Strong understanding of quality system requirements and topics, including trends in the medical device industry pertaining to compliance.
Possesses advanced ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.
Typically requires a minimum of 5 years of related experience with a Bachelor's degree; or 3 years and a Master's degree; or a PhD without experience; or equivalent work experience.
Experience with international and domestic regulatory compliance reporting requirements preferred.

Consultant:
David Gray

Tel no