Senior Quality Manager - Medical Device
Job Description
Sr. Quality Manager – Medical Device
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Location: Vista, CA
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Industry: Medical Device
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Employment Type: Full-Time
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About the Opportunity
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Our client is seeking an experienced Sr. Quality Manager to lead and strengthen Quality Systems within a growing medical device organization. This is an excellent opportunity for a hands-on Quality professional who enjoys working cross-functionally and making a meaningful impact on product quality, regulatory compliance, and overall business performance.
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The Quality Manager will be responsible for maintaining and continuously improving the company's Quality Management System while partnering closely with Operations, Engineering, R&D, Regulatory Affairs, and other functional teams.
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Key Responsibilities
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- Lead and manage day-to-day Quality activities and Quality Systems.
- Maintain compliance with applicable FDA, ISO 13485, and other medical device regulatory requirements.
- Manage and continuously improve the Quality Management System (QMS).
- Oversee CAPA, nonconformances, deviations, complaints, and corrective/preventive actions.
- Lead internal and external audits, including preparation, execution, and follow-up.
- Support supplier quality activities, including supplier qualification, monitoring, and corrective actions.
- Partner with Engineering and Operations on design changes, process improvements, validation, and product quality issues.
- Review and approve quality-related documentation, procedures, reports, and records.
- Establish and monitor Quality metrics and identify opportunities for continuous improvement.
- Investigate root causes of quality issues and drive effective corrective actions.
- Provide Quality guidance and training across the organization.
- Work closely with Regulatory Affairs to ensure alignment between Quality and regulatory requirements.
- Foster a culture of quality, accountability, and continuous improvement.
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Qualifications
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- Bachelor's degree in Engineering, Science, Quality, or a related discipline preferred.
- 8+ years of progressive Quality experience within the medical device industry.
- Prior supervisory and management experience with responsibility for developing teamsm managing performance, and leading quality initiatives.
- Strong knowledge of FDA Quality System requirements and ISO 13485.
- Experience with CAPA, nonconformances, audits, supplier quality, and quality systems.
- Experience working in a regulated medical device manufacturing environment.
- Strong problem-solving and root-cause analysis skills.
- Excellent communication and interpersonal skills.
- Ability to work effectively across Engineering, Manufacturing, R&D, Regulatory, and Operations.
- Hands-on, collaborative leadership style with the ability to balance strategic thinking with day-to-day execution.
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Preferred Experience
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- Experience with FDA inspections and/or notified body audits.
- Experience with risk management and ISO 14971.
- Experience supporting product development and design controls.
- Experience with process validation and/or equipment qualification.
- Experience implementing or improving an electronic QMS.
- ASQ certification (CQE, CQA, or similar) is a plus.
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