Job Title: Supervisor, Quality

　　Reports To: Director, Quality and Regulatory

　　Position Location: Buffalo, NY

　　FLSA Status (Exempt/Non-Exempt): FLSA Status: Exempt

　　Position Summary:

　　The Quality Supervisor position is a management position within the Quality and Regulatory Assurance Department at ZeptoMetrix Corp (Buffalo) that requires working knowledge of ISO 13485, and FDA 21 CFR 820 and other regulatory requirements.

　　The role will handle daily quality issues with internal customers and stakeholders. The role tracks and interprets statistical data relating to quality; recommends changes in standards, processes, equipment and materials to facilitate work and maintain quality. The role also interacts with other supervisors and managers to determine and resolve quality related issues.

　　Key Responsibilities:

　　Coordinates the daily quality system functions required to ensure manufactured products comply with ISO 13485 and FDA 21 CFR 820 as required.

　　Participates in internal and external audits.

　　Assists in preparing regulatory submissions.

　　Promotes and organizes training activities related to the Quality Management System and product quality and safety.

　　Provide troubleshooting and technical analysis, and tracking, for CAPA, Complaint, NCM, deviations, and other investigations to ensure compliance to applicable standards and verify implementation of corrective actions to ensure effective functioning of the Quality Management System.

　　Participating in internal and external audits, preparing audit responses, and tracking due dates and corrective actions to close audits.

　　Work on interdepartmental teams to perform risk management activities, design & development, supplier qualifications, and other team efforts and initiatives.

　　Track Quality metrics to monitor and ensure compliance, improve the quality system.

　　Organize and ensure that equipment validation, calibrations, and maintenance are monitored and performed.

　　Ensures the daily activities of the Quality Assurance Department are carried out to ensure effective functioning of the Quality Management System.

　　Performs other duties as assigned.

　　Minimum Requirements/Qualifications:

　　Bachelor’s degree from an accredited higher learning institution, preferably in a Biological, Quality or Engineering related field.

　　Prior experience or working knowledge of ISO 13485 and/or FDA 21 CFR 820 regulations.

　　Hands-on approach to troubleshoot and resolve quality related issues.

　　Detail and Quality focused with strong organization and negotiation skills.

　　Ability to present information and respond to questions from various levels within the organization

　　Proficient in the use of MS Office

　　Thrives in a fast-paced, collaborative environment, efficiently works under pressures, within deadlines or other time essential constraints.

　　Excellent communication skills, both written and verbal, to clearly and concisely communicate to all levels of the organization.

　　Experience with Minitab statistical software and / or advanced MS Excel skills would be considered an asset.

　　Strong work ethic and an ability to excel within a rapidly changing and growing organization.

　　Salary Range (varies based on location): $75,000-$90,000

　　This position has not been approved for Relocation Assistance.

　　The above statements are intended to describe the general nature and level of the work being performed by people assigned to this job. They are not an exhaustive list of all of the duties and responsibilities associated with it.

　　All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status.