Sr. Quality ManagerArtech LLC • Mountain View, CA
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Sr. Quality Manager
Artech LLC • Mountain View, CA
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- serp_jobs.job_card.full_time
job_description.job_card.job_descriptionGood documentation skills and attention to detail Experience with analytical, statistical, and trending analyses on complaint data Ability to recommend improvements in quality systems to ensure efficiency and effective controls Oversee a dedicated Quality Assurance team, providing guidance and direction across operational and functional areas Identify areas for process improvements and collaborate with management to develop effective solutions Manage and plan internal audits collaboratively with the Director of Regulatory Affairs Manage supplier quality assurance activities, including supporting new supplier approval and monitoring performance of existing suppliers Perform analyses on complaint data to support timely management review and proactive corrective action Review / write product investigation reports and provide analyses and trending data Ensure the Quality Management System is established, implemented, and maintained in accordance with regulations Develop formal written reports to communicate audit results to management and regulatory compliance agencies Escalate quality issues that could impact safety or efficacy Perform other duties as assigned by management Inclusive and diverse work environment Opportunities for professional growth and development Supportive team culture
Job Title : QA Manager / Quality Assurance Manager
Location : Mountain View, CA
Introduction
The Quality Assurance department is dedicated to ensuring safe, reliable, and effective products that exceed expectations. This department plays a crucial role in maintaining product and process quality, supporting commercial production for all products including laser consoles, delivery devices, and accessories.
Required Skills & Qualifications
- Applicants must be able to work directly for Artech on W2
- 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
- Ability to communicate complex technical issues clearly in English both verbally and in writing
- Demonstrated understanding of medical device QMS requirements and regulatory requirements, including 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
Preferred Skills & Qualifications
Day-to-Day Responsibilities
Company Benefits & Culture
For immediate consideration please click APPLY to begin the screening process with Alex / reach me at gracy.ingle@artech.com
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Sr Manager Quality • Mountain View, CA
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