Quality Control Coordinator

Quality Control Coordinator

The Quality Control Coordinator has primary responsibility for record-keeping and document management for our client's regulated businesses, including Medical Device, Pharmaceutical, Life Sciences and Microelectronics. The Quality Control Coordinator will interface with all levels of sales and operations, both within the US and Internationally, and will follow-up on and report on project status. The qualified candidate will have prior experience with documentation and project management within a life science company that maintains an ISO13585, cGMP quality system.

Job Responsibilities

• Manage finished product specification files.
• Organize and process ISO 90001, ISO 13485 and cGMP procedures.
• Submit sample requests for our international manufacturing facilities.
• Be a lead contact with the FDA to coordinate approvals and documentation.
• Resolve any documentation issues related to labeling and quality control.
• Maintain MRB (Material Review Board) to correct product and issue releases.
• Uphold all elements of the Site Quality Policy.

Qualifications:

KNOWLEDGE, SKILLS, and ABILITIES - High level of organizational skill is required. Ability to work independently, in a fast paced, high-pressure environment. Advanced knowledge of Microsoft Excel, Word, and Outlook. Advanced communication and problem-solving skills. REQUIREMENTS - 4-year college degree (Bachelors) in Science, or equivalent. 5+ years experience in regulatory affairs, product development, or product manufacturing in a Management capacity. Familiarity of FDA medical regulations as well as ISO 90001 and ISO 13485

Why is This a Great Opportunity:

Our client company is an international market leading medical device company focusing exclusively on Class 1 products. The company has a strong 50 year presence in the industry and is experiencing rapid growth. They are constructing a new production facility in Central Texas to offset overseas production. This is an opportunity to build a process and team from the ground up. This position will be responsible for developing a full site plan as well as having significant input on their team.