Quality Systems Specialist

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Job description

Achieva currently have an Opportunity for Quality Systems Specialist to work for a Medical Device Company.

*The Role:*

* Provides oversight for the development and maintenance of quality programs, systems, processes, and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.
* Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
* Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.
* Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.
* Prepare reports and/or necessary documentation (ex-Corrective and Preventative Actions) and provides to applicable stakeholders, both internal and external.
* Co-ordinates legal requests in support of government investigations or litigations.
* Ensures the quality assurance programs and policies are maintained and modified regularly.
* Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of the company's mission globally.
*Skills and Qualification*

* Bachelor's Degree
* 3+ years of experience in either an IT role or an engineering role with a BA/BS degree
* Ability to communicate effectively, both verbally and in written form
* Experienced in project management
* Experience to work in a global, virtual organization
* Good understanding project management lifecycle (e.g. waterfall or agile)
* Strong hands-on experience in Excel sheets - complex formulae, pivots, pivot charts etc.
* Basic working knowledge of Microsoft SharePoint
* Excellent skills in analysing data and report creation
* Good interpersonal skills
* Ability to communicate and document complex issues and procedures
* Ability to work in a fast-paced environment
* Ability to work well under pressure and maintain positive, enthusiastic attitude
* Eagerness to learn and expand responsibilities
* Ability to work effectively in a team environment and build strong working relationships
* Strong communication skills, including with employees, clients, senior management and vendors
* Strong results orientation (driving to deadlines, financial targets, project goals, etc.)