Quality Assurance Manager - Medical Device

Description

Company Description

My client provides pharmaceutical and biopharmaceutical manufacturers with a comprehensive suite of tools to maximize safety and improve yields of biotherapeutics during research, clinical and commercial-scale production. Planova™ virus-removal filters anchor a diverse product portfolio defined by quality, consistency and scalability. Additional areas of expertise include liquid chromatography, inline buffer dilution and oligonucleotide synthesis.Job Description

The Quality Assurance Manager creates, administers and oversees the quality-related efforts of the company, including process/procedure standardization, optimization of SOPs, documentation & regulatory compliance, safety & environmental practices, responding to customer quality issues and resolving warranty claims.
Essential duties and responsibilities include:

• Review and update Quality Management System for production of custom systems and other standard products (resins and membranes) with guidance from subject matter experts, review product and processes for functionality and effectiveness
• Develop and implement corrective action plans for products & processes
• Respond to customer/management/regulatory quality inquiries and audits (questionnaires, agreements, claims, reports)
• Leads the Safety Committee, improving safety practices & procedures
• Review and improve standard operating procedures & conduct training
• General administrative efforts (supervision of staff, meetings, reports, etc.)

Additional duties and responsibilities include:

• Create and maintain QA database (calibration standards, MSDS, etc.)
• Special projects, as assigned
• Mechanical (or related) Engineering Degree
• Minimum 5 years experience leading the Quality effort in a manufacturing environment.
• Experience in quality management of raw materials (vender or customer) in a pharmaceutical or biotech setting preferred.
• Experience with quality aspects of equipment used in biopharmaceutical production preferred.
• Experience of obtaining ISO/GMP certification preferred.
• Exceptional written and verbal communication skills
• Exceptional analytical skills to solve problems associated with the determination of root causes.
• Exceptional influencing skills

Desired Skills & Experience:

• Mechanical (or related) Engineering Degree
• Minimum 5 years experience leading the Quality effort in a manufacturing environment.
• Experience in quality management of raw materials (vender or customer) in a pharmaceutical or biotech setting preferred.
• Experience with quality aspects of equipment used in biopharmaceutical production preferred.
• Experience of obtaining ISO/GMP certification preferred.
• Exceptional written and verbal communication skills
• Exceptional analytical skills to solve problems associated with the determination of root causes.
• Exceptional influencing skills

To find out more about Real, please visit www.realstaffing.com