Flex

Austin, TX

The Sr. Quality Control Manager will be based in Austin, TX reporting to the Quality Director. In this role, you will develop, implement, and coordinate product assurance program to prevent or eliminate defects in new or existing products.

What a typical day looks like:

• Oversees Inspection (incoming, in process, finished devices) and Supplier Quality personnel to meet internal and customer’s requirements for raw materials, components, sub-assemblies, and finished devices from suppliers and Medical personnel and monitoring their compliance to 21 CFR 820 and ISO13485.
• Leading and managing Supervisors, Engineers, inspectors, technicians, and other staff members in Quality Control and Supplier Quality areas as well as providing medical device guidance to support 24/7 contract manufacturing operation.
• Gaining an understanding of the internal and external needs and requirements and communicating them to Operations to meet business and compliance goals.
• Provide guidance with Operations, Engineering, and Quality to improve the manufacturing process to ensure higher-quality products and address issues including process improvements to meet business expectations and compliance.
• Review and/or provide input in specifications and procedures for products or processes, and training staff accordingly with focus on defect recognition.
• Collaborate with Operations, Engineering and Quality to identify, address, and support deviations and/or non-conformances in a timely manner.
• Gaining feedback from the customers, attending key meetings, submitting reports to management, and assisting external auditors and inspectors.
• Support internal and external audit preparations and execution as applicable.

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The experience we’re looking to add to our team

• 5-10 years management of Quality Control in manufacturing and medical industry production environment (contract manufacturing preferred).
• In-depth working knowledge of GMP, Quality Control, and medical device standards and regulations (21 CFR Part 820, ISO13485).
• Strong attention to detail, communication, listening, organizational, and leadership skills.
• Willingness to be "hands on" to achieve objectives and work autonomously under pressure
• Strong knowledge of inspections, data analysis, and IT skills (ERP, QMS, and eDHR software systems preferred).

Here are a few of our preferred experiences:

• QA/QC certification, auditor certification, and/or project management experience
• Clean room experience
• SQC/ supplier quality experience

Here are a few examples of what you’ll get for the great work you provide…

• Full range of medical benefits, dental, vision
• Life Insurance
• Matching 401K
• PTO
• Tuition Reimbursement
• Employee discounts at local retailers