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This range is provided by Provisio Medical. Your actual pay will be based on your skills and experience talk with your recruiter to learn more.
Base pay range
$120,000.00/yr - $150,000.00/yr
Company Overview:
Provisio Medical, Inc. is a pioneering medical device company focused on developing innovative intravascular ultrasound (IVUS) technologies to improve cardiovascular imaging and outcomes. We are a fast-paced, mission-driven organization committed to clinical excellence, regulatory compliance, and delivering transformative medical technologies.
Position Summary:
TheSenior Manager, Quality Assurance will lead and manage all aspects of the Quality Assurance function at Provisio Medical. This individual will ensure compliance with FDA, ISO, and global regulatory requirements while fostering a culture of quality and continuous improvement. The role includes strategic leadership, team development, and hands-on management of quality systems and processes critical to the design, manufacture, and support of Class II medical devices.
Key Responsibilities:
- Provide leadership and direction in quality matters to ensure product quality and regulatory compliance in alignment with corporate goals.
- Effectively lead and build a high-performing quality team, fostering a culture of continuous improvement and accountability.
- Act as theManagement Representative , providing regular feedback to executive leadership on the effectiveness of the Quality Management System (QMS) and product performance.
- Own, maintain, and improve the QMS to meet FDA 21 CFR Part 820, ISO 13485, and other applicable standards.
- Collaborate with the Director of Design Assurance to write, review, and maintain SOPs and related documents, including cross-departmental SOPs.
- Manage document control processes and maintain electronic QMS (eQMS) and related quality software systems.
- Oversee the quality review and approval of change requests related to components, parts, assemblies, and production processes.
- Manage and oversee:
- Receiving inspection processes
- Line quality control activities
- Equipment calibration and maintenance tracking
- Training system administration and compliance tracking
- Non-conforming material handling and disposition
- Maintain an effective feedback and complaint handling process, ensuring timely investigation, documentation, and resolution.
- Lead the CAPA system to drive root cause analysis, corrective actions, and preventive strategies across departments.
- Plan, schedule, and manage the internal audit program, including auditor selection, audit criteria development, and corrective action follow-up.
- Collaborate with cross-functional departments to resolve findings from internal and external audits.
- Facilitate the registration and maintenance of the facilitys regulatory classification in accordance with applicable standards.
- Lead quality data collection, analysis, trending, and reporting to identify performance gaps and areas for improvement.
- Oversee supplier quality management, including approval, qualification, audits, and ongoing performance evaluation.
- Coordinate and manage supplier audits and quality agreements.
- Provide oversight of product, process, and component non-conformances to ensure timely resolution and regulatory compliance.
- Support Regulatory Affairs in maintaining certifications, regulatory submissions, third-party audits, and agency inspections.
- Participate in cross-functional collaboration on product development, production readiness, and risk management.
- Perform other related duties as assigned by executive leadership.
Qualifications:
- Bachelors degree in Engineering, Life Sciences, Applied Science, or a related field (advanced degree preferred).
- 810 years of quality assurance experience in the medical device industry.
- At least 3 years in a QA leadership or management role.
- Strong knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 14971, and other applicable standards.
- Experience authoring and implementing QMS documentation and participating in FDA and ISO audits.
- Familiarity with eQMS platforms and document control tools.
- Proven track record managing quality systems, audits, supplier quality, and cross-functional collaboration.
- Excellent leadership, communication, and analytical skills.
Preferred Qualifications:
- Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), or similar credentials.
- Experience in IVUS, catheter-based technologies, or diagnostic imaging devices.
- Familiarity with MasterControl, Greenlight Guru, Arena, or similar systems.
- Competitive salary and equity package
- Medical, dental, vision, and life insurance
- 401(k) plan
- Generous PTO and flexible work schedule
- Opportunity to work in a high-growth, impactful medical device company
Provisio Medical, Inc. is an equal opportunity employer. We value diversity and are committed to fostering an inclusive environment.
Seniority level
Seniority level
Director
Employment type
Employment type
Full-time
Job function
Job function
Quality Assurance-
Industries
Medical Device
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