Senior Program Manager Quality (Medical)

Job Description

The Senior Program Manager Quality (Medical) will be based in Austin, TX.  The Senior Program Manager Quality (Medical) will manage execution of the quality requirements and support of the site Quality organization to conform and comply with Medical Quality standards and regulations, internal policies, directives, and procedures to achieve and exceed the quality objectives expected by the customer and the organization.

Coordinates the development and implementation of Medical Quality strategies and projects with Flex management to meet internal and external objectives.

Here is a glimpse of what you’ll do…

• Management of the Quality Program management process to assure the conformance of regulatory and quality systems requirements.
• Optimize site Quality process and improvements with cross functional teams and management to meet timelines and compliance.
• Monitors, reports, and coordinates Quality projects and accountable to track project completion on time to comply with the customer metrics and/or internal objectives.
• Analyzes the Quality data gathering and results for applicable Quality project review meetings.
• Coordinates problem solving, and escalates challenges encountered on the program that affect Quality and to meet commitments, accountable for the project performance and address any gaps to assure alignment.
• Engage in External Audit Processes (Customers', Regulatory, Government Agencies, etc.), audit preparations, and identify opportunities for improvement with Quality management.
• Participating in overall Quality and Site Operational Excellence/Improvement activities.
• Support Quality training programs in subjects related to Regulations or Quality Systems.
• Act as SME for medical device Quality Systems and engage in ongoing process improvements and system operations as needed.

Here is some of what you’ll need (required)…

• 10 years of Quality management experience required in Medical Devices (FDA CFR 820, ISO 13485)
• Additional roles/experience in Quality Operations preferred
• Experience in Contract Manufacturing preferred
• Familiarity with International regulatory requirements preferred but not necessary
• ISO 13485 Lead Auditor Certification preferred
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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