Vice President Quality Assurance - Permanent - Onsite
Proclinical is seeking a Vice President Quality Assurance to join a cutting-edge medical device company. This is a permanent role located in Mountain View, CA.
Primary Responsibilities
The Vice President, Quality Assurance is a key leadership role responsible for developing, implementing, and maintaining the quality management system to ensure the highest level of product quality and regulatory compliance by collaborating across departments. This role involves building and leading the Quality Assurance team of professionals, defining product quality standards, defining the quality system documentation and infrastructure, establishing quality processes and monitoring metrics for compliance. This role involves overseeing the quality management system, quality compliance, process improvement, and quality control initiatives meeting all worldwide markets.
Skills & Requirements:
- Bachelors in engineering, masters degree preferred.
- 10+ years of interventional vascular medical device experience.
- Technical leader with expertise in strategic planning, technical talent acquisition/training, management and retention.
- Highly diverse background with an ability to develop alliances with OEM companies and field experts to enhance and complement technical capabilities.
- Experience with design control, process development, product validation, pre-clinical GLP studies and clinical evaluations.
- Experience with biodegradable polymeric implants and polymer processing.
- Experience with stent and delivery system design and process.
- Experience with drug delivery devices.
- Excellent management, interpersonal and communication skills.
- Has implemented medical devices from design through validation, into clinical evaluation and to commercialization.
- Ability to manage multiple engineering and business projects.
- Thorough knowledge of Microsoft Office, Project, and SolidWorks.
- Must be eligible to work in the US.
The Vice President Quality Assurance will:
- Quality Management System (QMS) Leadership & Strategy:
- Monitor, implement changes and maintain QMS to meet the organization's quality objectives and requirements worldwide.
- Establish and monitor key performance indicators to measure the effectiveness of the QMS.
- Manage the core quality system activities and deliverables to maintain compliance to international medical device regulations and certifications.
- Formulate, write and maintain procedures, specifications and standards for the quality control of products to ISO 13485, MDR and 21 CFR 820.
- Stay current with relevant industry regulations and standards.
- Provide guidance to employees on quality system quality regulation requirements. Ensure the organization's compliance with applicable regulatory requirements, such as FDA, ISO, or other industry-specific standards.
- Regulatory Compliance:
- Stay current with relevant industry regulations and standards.
- Ensure the organization's compliance with applicable regulatory requirements, such as FDA, ISO, or other industry-specific standards.
- Quality Assurance:
- Develop and execute a comprehensive quality management system that aligns with the organization's goals and objectives.
- Identify and mitigate quality risks across the organization.
- Maintain training system records and processes for the QMS required training.
- Maintain supplier management records and files.
- Maintain the complaint management records and processes.
- Quality Control:
- Implement effective quality control processes and methodologies to monitor product quality.
- Lead investigations and root cause analyses for quality issues and implement corrective and preventive actions (CAPAs).
- Documentation and Reporting:
- Maintain accurate and comprehensive quality documentation, including records of audits, inspections, and quality reports.
- Prepare and present quality-related reports to senior management.
- Process Improvement:
- Continuously assess and improve quality-related processes and procedures.
- Collaborate with cross-functional teams to optimize workflows and enhance product or service quality.
- Stakeholder Communication:
- Effectively communicate quality-related information to internal and external stakeholders, including customers, regulatory agencies, and auditors.
- Team Management:
- Recruit, train, and mentor a high-performing team of quality professionals.
- Set performance expectations, conduct regular performance reviews, and promote professional development.
If you are having difficulty in applying or if you have any questions, please contact Christina Chung at (+1) 857-233-9215 or c.chung@proclinical.com.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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