QA Manager #1227

Organization: 
San Diego County based Diagnostics Organization
Job Location: 
San Diego
Job Description: 

The QA Manager will be responsible for the management of the site’s quality tactical activities to assure compliance to the company’s quality system requirements and Federal/State regulations.

Duties include:
• Maintain soverall compliance of the company’s quality system.
• Manages team of quality engineering staff.
• Ensures company products and procedures meet Quality System Regulations (QSR) 21 CFR Part 82
• Leads the quality audit programs (internal and supply chain). Responsible for maintaining the audit schedule, assigning actions to managers/suppliers and ensuring that all audit findings are closed in a timely manner. Conducts regular assessments to prepare the company for scheduled or unannounced Federal & State inspections and maintains the ISO 13485 Certificate.
• Leads GMP training programs for company personnel
• Prepares clear and meaningful Quality System metrics for Management Reviews or for weekly/monthly monitoring.
• Ensure that quality records for CAPA, complaints, nonconforming material reports, change orders, protocols, reports, etc. comply with internal procedures and cGMP. Guide departments in technical writing principles for drafting records in a regulated industry.
• Guide teams in the identification, disposition, and corrective actions of material and process nonconformances.
• Regularly monitors the quality system to ensure systemic issues and/or negative trends are quickly addressed and corrected.
• Supports development and implementation of a new electronic Quality System (CAPA, complaints, field service, audits, nonconforming material reports, calibration)
• Provides guidance to operations and development teams in design control, process validation, design/process changes, and risk management (hazard analysis, FMEA).
• Ensures complaint and CAPA programs operate at the highest level of effectiveness and compliance.
• Supports manufacturing and test operations including but not limited to batch record review, equipment compliance (calibration/PMs), production and process controls, sampling plans and quality control.

Requirements: 

• Bachelor Degree in the sciences, life sciences, or engineering; advanced degree preferred.
• 5 or more years of relevant FDA regulated industry experience with 3-5 years as a QA or QE Manager.
• Combination of QA and regulatory affairs experience a plus.
• Experience in preparing for and managing Federal and State inspections, ISO 13485/ European Directives/ Notified Bodies, and U.S. FDA Quality System Regulatory Compliance inspections.
• Technical knowledge of molecular biology and genetic testing laboratory practices (CLIA, ASR, IVD).
• Experience with product development process (design controls) and manufacturing of medical devices especially for diagnostic tests.
• Experience in basic statistical analysis tools, Design of Experiments (DOE), root cause analysis and Six Sigma methodologies preferred.
• CE marking experience preferred.
• Strong people management skills.
• Solutions oriented business partner.

Contact Information: 

Apply on-line today by emailing your resume to: Recruit@alcockmcfadden.com