Job Description

Position Overview

Ultimate Staffing Services is actively seeking a Senior Quality Manager for a prestigious client in the medical device industry located in Mountain View, California. This role involves leading the Quality Assurance department, ensuring the delivery of safe, reliable, and effective products that meet and exceed customer expectations. The position demands strategic oversight, quality systems management, and collaboration with various departments to address and solve quality issues.

Responsibilities

• Oversee a dedicated Quality Assurance team, providing guidance and direction across operational and functional areas to ensure product and process quality.
• Proactively identify areas for process improvements and collaborate with management to develop effective solutions aligned with business objectives.
• Manage and plan internal audits collaboratively with the Director of Regulatory Affairs.
• Manage supplier quality assurance activities, including supporting new supplier approval, monitoring performance of existing suppliers, and performing supplier quality audits.
• Perform analytical, statistical, and trending analyses on complaint data to support timely management review and proactive response or corrective action.
• Review and write product investigation reports. Provide analyses and trending data, including initiating formal investigations and/or corrective action requests resulting from product complaints.
• Ensure that the Quality Management System is established, implemented, and maintained in accordance with established regulations (FDA, ISO13485, & other International requirements) and report on the performance of the quality management system to management for review and as a basis for improvement.
• Evaluate existing quality system procedures and processes for compliance with applicable regulatory requirements.
• Develop formal written reports to communicate audit results to management and regulatory compliance agencies.
• Escalate to direct management all quality issues that could impact patient safety or surgical efficacy.
• Perform other duties as assigned by management.

Qualifications

• Bachelor's Degree.
• Minimum 5-7 years of Quality Assurance experience with at least 2 years in the medical device industry.
• 2 years of experience managing people/teams.
• Advanced problem-solving skills, including troubleshooting and root cause analysis.
• Must be able to communicate complex technical issues clearly in English both verbally and in writing.
• Demonstrated understanding of medical device QMS requirements and regulatory requirements, including but not limited to ISO 13485:2016, 21CFR820, and MDSAP.
• Familiarity with risk management tools.
• Knowledge of quality system auditing; auditing certifications (e.g. lead auditor, quality auditor, biomedical auditor) are a plus.

Required Work Hours

Monday - Friday, 1st shift.

Benefits

This position offers a competitive salary ranging from $165,000 to $175,000 annually, depending on experience.

Additional Details

This job is a supervisory position, providing an excellent opportunity to lead and influence the quality assurance operations within a dynamic and innovative company.

All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, and Los Angeles County Fair Chance Ordinance. For unincorporated Los Angeles county , to the extent our customers require a background check for certain positions, the Company faces a significant risk to its business operations and business reputation unless a review of criminal history is conducted for those specific job positions.

Job Tags

Local area, Monday to Friday, Day shift,

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