Director of Quality Assurance

Director Of Quality Assurance

This position will lead all Quality Assurance functions between two medical device production facilities. The two facilities consist of a production plant in Taiwan as well as a new production plant in Central Texas. The facility in Central Texas is currently under construction and will be the base location for this position. Some travel to Taiwan will be necessary.

The Director of Quality Assurance (QA) Manager is responsible for the development of new quality standards and operating protocols. Leading a team of 4-6 employees, they are tasked with ensuring and maintaining the overall effectiveness of the Site Quality Program. This includes, but is not limited to complying with ISO 13485 and 21 CFR 820 to verify product standards are met. The Director of QA will also be the lead contact for all government regulatory agencies, include the FDA and ISO. A strong candidate will have experience as a lead for FDA inspections and audits.

Job Responsibilities:

• Responsible for overall effectiveness of Site Quality Program.
• Function as the Management Representative for all regulatory bodies and agencies.
• Ensure that the Quality System requirements are effectively established and maintained in accordance with 21 CFR 820
• Establish Quality Plan which defines quality practices, resources, and activities relevant to our clients products that are manufactured.
• Responsible for establishing Quality System procedures and instructions.
• Establishment of robust supplier quality initiatives and audits.
• Establish and maintain Site Internal Audit program and schedule.
• Oversee MRB (Material Review Board) process.
• In accordance with 21 CFR 820, Lead Management Review with Senior Management Team within pre-determined intervals.
• Oversee and manage the Site CAPA (Corrective and Preventative Actions) system.
• Manage the quality department personnel to ensure that all Quality objectives are completed in a timely manner.
• Responsible for management of both receiving inspection as well as production inspection processes.
• Ensure compliance with cGMP standards.
• 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 ISO 13485 as well as 21 CFR 820 - 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. Six Sigma Certification a plus - Lean Manufacturing Certification a plus - ISO Lead Auditor Certification a plus

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.