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Job Description
Site Operations Quality Manager ClearCorrect - 3.3 Round Rock, TX Job Details Full-time $115,000 - $125,000 a year 15 hours ago Benefits Health insurance Dental insurance 401(k) Paid time off Vision insurance Qualifications Defect resolution root cause analysis Team leadership ISO standards Preventive action implementation Production deviation management Quality control preventive actions Corrective and preventive actions (CAPA) Manufacturing facility Supervising experience Medical device manufacturing facility experience Pharmaceutical company experience Leading team collaboration initiatives Regulatory/legal compliance standards in production Biomedical regulatory compliance Product quality failure Failure analysis Pharmaceutical manufacturing facility experience Full Job Description #ChangeMakers Ready to make an impact? We develop, manufacture, and supply dental implants, clear aligners, instruments, CADCAM prosthetics and biomaterials for use in esthetic dentistry, tooth replacement and restoration solutions or to prevent tooth loss. We empower our employees to perform and make an impact, to question the status quo, to drive change, to stay ahead of the competition. From the first Dental Implant in 1974 to the latest Digital Solution - we do things differently than others We deliver innovation based on evidence. This is part of our employer culture as well as an exceptional team spirit that truly encourages diversity and a powerful "can-do" attitude. #WeChangeDentistry every day. Be part of it. Position Summary 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. Essential Functions and Duties 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 Work Environment Manufacturing environment with routine presence on the production floor and occasional travel for audits or collaboration. Minimum Qualifications 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. Preferred Qualifications Professional certifications (ASQ, Lead Auditor) Strong execution and operational focus, team leadership, cross-functional collaboration, problem-solving, and data-driven decision making.
Salary:
$115,000 - $125,000/Annually. The final pay for this position will vary based on geographic location and candidate experience relative to what the company reasonably anticipates for this position. Whether you're looking to build your career, improve your health, or brighten your SMILE, we offer generous benefits to help you achieve your goals. 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! Please understand that we do not need external support by recruiting agencies and consultants to fill this vacancy. Thank you for respecting this.
Videos To Watch https:
//youtu.be/3lq5BLAvIdQ All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or disability.
