HireDiversity

Inverness, GB

Quality Systems Specialist-00000A5X

Description

Opportunity to provide technical Quality Systems leadership to the business in order to ensure the highest levels of product quality, process, and systems integrity to the customer.

LifeScan Scotland has a history of innovation in Inverness. Now part of Johnson & Johnson, LifeScan was originally established in 1995 to design and manufacture specialist technology for the global diabetes market. In addition to developing and producing a range of test strips for diabetic populations, we also design and develop meters and other related devices for the management and control of diabetes. Our vision is: 'creating a world without limits for people with diabetes'.

As a Quality Systems Specialist 1, you will be responsible for;
- The administration and execution of applicable Quality System processes and procedures while facilitating its use by business partners.
- Managing and prioritizing the daily issuance, evaluation, tracking, reconciliation and archiving of quality system information.
- Supporting the development and implementation of quality systems based on business regulatory and customer requirements.

Duties include;
- Administrate electronic systems that support applicable quality systems.
- Provide ongoing advice, guidance and support to customers on the process and the use of the supporting Software.
- Development of training materials and facilitation of training.
- Troubleshoot and escalate issues as required.
- Perform periodic routine checks to verify appropriate application.
- Verify that quality systems are effectively deployed.
- Collect and compile quality data for reports, perform follow up actions and metrics.
- Assist in determining root causes of quality issues and develop corrective actions and recommendations.
- Suggest process and software changes when appropriate.
- Participate on cross department project teams and in quality system improvement initiatives, owning actions and deliverables.
- Assist with internal and external audits, generate reports with corrective action plans and ensure implementation of corrective actions in a timely fashion.

Using your expertise and knowledge of our systems you will identify opportunities for improvements and contribute to global projects. You will be recognised as a subject matter expert in your area of responsibility. You will also have the opportunity to lead activities such as, quality metric improvements, root cause analysis, problem solving.

This is a great career development opportunity. Furthermore, Inverness, located in the beautiful Scottish Highlands, is a relatively small city with a population of 65,000, offering an outstanding quality of life, excellent schools and colleges, leisure facilities and good transport links.

Will government officials please identify themselves on application for the purpose of the Foreign Corrupt Practices Act. If you apply for the role, any personal data which you provide shall be processed by LifeScan Scotland, a Johnson & Johnson company, for the purpose of recruitment, recruitment policy and selection.

Qualifications


Qualifications


Required Criteria:
- Minimum of Secondary/High School education.
- Experience of working with Quality Systems
- Proficient in using software system, understanding of functionality.
- Working knowledge of regulatory and compliance environment i.e. ISO 13485:2003; 21 CFR Part 820, ISO 14971 and ISO 15197
- Ability to multi task and work to defined priorities.
- Results & Performance Driven
- Trouble shooting and problem solving skills
- Verbal and written communications

Desirable Criteria:
- Degree Qualification in engineering or other appropriate discipline.
- Formal Problem solving techniques, e.g. PeX Green Belt.
-Project management experience.
- Experience of training creation, delivery and working with training management systems.
- Experience of dealing with Statistics & Metrics
- Knowledge of diabetes

Primary Location:Europe/Middle East/Africa-United Kingdom-Scotland-Inverness
Organization: Lifescan Scotland Limited (form. Inverness Medical (7691)
Job Function: Quality (Generalist)