Site Operations Quality Manager

Straumann • Round Rock, TX

1d • $115,000 - $125,000 • Hybrid

About The Position

The Site Operations Quality Manager is responsible for leading site-level Quality Operations, including Quality Assurance, Quality Engineering, Quality Control, and Quality Systems. This role ensures that site manufacturing and support processes consistently meet regulatory requirements and internal standards. The position focuses on execution, compliance, and continuous improvement at the site level while aligning with global quality strategies.

Requirements

• Bachelor’s degree in Engineering, Science, or related discipline.
• 5+ years of experience in quality within a regulated med device or pharmaceutical manufacturing environment.
• Prior experience in a site-based quality leadership or supervisory role.
• Working knowledge of FDA QSR, ISO 13485, and applicable regulatory requirements.
• Experience with audits, CAPA, nonconformance management, and root cause analysis.

Nice To Haves

• Professional certifications (ASQ, Lead Auditor)
• Strong execution and operational focus, team leadership, cross-functional collaboration, problem-solving, and data-driven decision making.

Responsibilities

• Lead day-to-day site Quality Operations supporting manufacturing, process control, and product release
• Ensure compliance with FDA, ISO 13485, MDR and regulatory requirements
• Implement and maintain the Quality Management System (QMS) in alignment with global standards and regulatory requirements
• Ensure the site maintains a continuous state of inspection readiness and compliance
• Manage nonconformance, CAPA, and deviation processes to ensure timely and effective resolution
• Monitor and report site quality metrics and KPIs; drive corrective actions and continuous improvement at the site
• Support manufacturing operations through quality engineering, process validation, and change control activities
• Partner with site leadership (Operations, Engineering, Supply Chain) to resolve quality issues and improve process capability
• Lead site audit activities including internal, customer, and regulatory inspections and ensure closure of findings
• Develop, coach, and manage site Quality team members, including performance management and training
• Support new product introductions and transfers to ensure compliant and effective site implementation
• Ensure effective communication and escalation of quality issues to site and global leadership as appropriate
• Drive adoption of standard processes, procedures, and best practices across the site
• Promote a strong quality culture focused on compliance, accountability, and continuous improvement

Benefits

• Very Competitive total compensation plans (some positions include discretionary bonus, or Performance Share Units).
• A 401(K) plan to help you plan for your future with an employer match
• Great health, dental and vision insurance packages to fit your needs to ensure you’re happy and healthy. Straumann contributes a healthy portion towards employees’ premium.
• Generous PTO allowance - plenty of time to recharge those batteries!

What This Job Offers

• Job Type: Full-time
• Career Level: Manager