Quality Assurance Manager

About the role

The Quality Assurance Manager oversees various aspects of quality systems and processes at Ovik Health's Mayflower Plant in Salisbury, MA. They are responsible for developing, implementing, and maintaining a quality system compliant with FDA QSR and ISO 13485 standards. The role also involves managing and maintaining inspection and product release programs, setting quality assurance objectives, and conducting management reviews.

Responsibilities

• Develop, implement, and maintain a quality system compliant with FDA QSR and ISO 13485 standards
• Liaison with ISO 13485 registrar to ensure activities are completed for ISO 13485 registration
• Manage and maintain quality inspection and product release programs for raw materials, in-process materials, components, and finished goods
• Set quality assurance objectives for Top Management and ensure targets are achieved
• Establish and maintain appropriate controls and documentation procedures
• Participate in new product development activities to ensure proper quality assurance and control plans can be implemented
• Support an effective supplier quality assurance system while ensuring supplier corrective actions are timely and effective
• Implement new inspection, measurement, and testing systems for quality monitoring and improvement
• Track and report significant quality deviations
• Develop and maintain an effective quality systems training program for all appropriate business associates
• Manage all audit activities including internal, external, supplier, and FDA audits
• Conduct Management Reviews on a regular basis for location of responsibility
• Develop, edit, review, and approve validation protocols and reports
• Provide employee development opportunities for direct reports
• Own CAPA, NC, and Complaint programs for location of responsibility

Requirements

• Strong verbal and written communications skills
• 4+ years Quality Assurance experience including 2 + years of supervisory leadership
• ISO and FDA Quality systems knowledge
• Bachelor's Degree in Science or Management preferred
• Medical Device manufacturing desirable

Physical Requirements

• Frequent standing: 60%
• Sitting: 40%
• Moving: 100%
• Lifting: 100%
• Ascending/Descending: 50%
• Pushing/Pulling/Reaching: 5%
• Bending: 25%
• Visual Acuity: 100%
• Cognitive: 100%

Work Environment/Safety-Sensitive Position

This job operates in a manufacturing facility. This position is a safety-sensitive position and occasionally works around moving mechanical parts and powered industrial vehicles. Noise levels can be medium to loud. Temperatures can vary depending upon the time of year and outside impacts.

Pay

The salary range for this position is $91,500.00 to $135,000.00; the exact range depends on several factors such as experience, skills, education and budget.