Quality Assurance Manager

Quality Engineer / Quality Manager About Pensar Medical

Pensar Medical is a rapidly expanding medical device company based in the Houston area, specializing in innovative wound care products designed to meet diverse patient needs. As we continue to grow, we're committed to maintaining the highest standards of quality, compliance, and innovation in everything we do.

We are seeking a talented and reliable Quality Engineer / Quality Manager to join our dynamic team. In this role, you will play a key part in ensuring that our processes and products exceed company, regulatory, and customer quality standards. This includes leading investigations, managing quality systems, and fostering a culture of continuous improvement. If you're a proactive problem-solver with a passion for quality in the medical device industry, we encourage you to apply.

• Managing investigations and root cause analyses for customer complaints, audit observations, and Corrective and Preventive Actions (CAPAs).
• Reviewing, revising, and conducting training on Standard Operating Procedures (SOPs).
• Creating, monitoring, and reporting on quality system and business metrics.
• Promoting and maintaining a quality-driven culture throughout the organization.
• Assisting in the development and maintenance of the Quality Management System to ensure compliance with global regulations, including US FDA (21 CFR 820), ISO 13485, and others.
• Participating in and collaborating on global and local regulatory strategies for existing and new product development.
• Aligning internal processes and metrics to achieve the highest product quality, operational efficiency, and competitive advantage.
• Maintaining records and investigations related to non-conformances, corrective actions, and customer complaint systems.
• Supporting product development activities, including concept generation, decision matrices, prototyping, manufacturing, verification, validation, and associated metrics.
• Ensuring the ongoing maintenance of Design History Files (DHFs) and Technical Files for all product lines.
• Assisting Engineering teams with investigations, qualification, verification, and validation protocol development, execution, and report generation.
• Supporting Manufacturing by developing process descriptions, maintenance procedures, and training staff as needed.
• Participating in performance improvement initiatives, utilizing resources efficiently, and taking responsibility for personal professional development.
• Other related duties may be assigned to meet business needs.

• Bachelor's degree in Engineering, Quality Assurance, or a related field.
• 3+ years of experience in quality engineering or management within the medical device industry, with a strong understanding of regulatory requirements (e.g., FDA, ISO 13485).
• Proven experience in root cause analysis, CAPA management, and quality system maintenance.
• Familiarity with product development lifecycle, including verification and validation processes.

• Strong ability to articulate ideas clearly, with professional oral and written communication skills.
• Excellent technical reading and writing abilities.
• Proficiency in Microsoft Office suite and CAD software.
• High energy, flexibility, and self-starter mentality.
• Exceptional attention to detail and precision in work.
• Ability to prioritize and multitask with minimal supervision.
• Demonstrated "out-of-the-box" thinking, conceptual design, and analytical skills; self-motivated, flexible, and detail-oriented.
• Professional demeanor and attitude, with the ability to communicate effectively with customers and stakeholders at all levels.
• Solid understanding of engineering-level mathematics and physics.
• Capability to interpret and create engineering schematics and drawings.