Senior Quality Assurance

4 months ago

South East, United Kingdom On Target Recruitment Ltd Full time

**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. 0208 397 4114

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