Provide leadership for day-to-day operations of Quality Assurance and Document Control functions. Ensure that all goods manufactured by the Company meet the requirements of the Quality Management System and applicable regulatory requirements. Provides input to all functions and departments on Quality related principles. Key Responsibilities:
Manage daily operations of and oversee Quality Assurance and Document Control department staff in the performance of their respective duties. Responsible for related HR activities, including interview, disciplinary and performance evaluation tasks. Identify needs for, and provide training, development and support.
Understands practical application of GMP and ISO principles. Writes and/or revises and executes Quality related procedures.
Performs and/or oversees QA review and ensures products are manufactured within the guidelines of the QMS and relevant regulatory agencies and in a timely manner according to scheduled ship dates.
Representative for Quality in planning and scheduling meetings as well as Design Control. Completes phase deliverables related to Quality and provides guidance to the team of practical application of products into the existing QMS.
Conduct initial new employee training of the QMS in accordance the established Training program.
Oversee use and management of the Document Control system. Ensures that effective documents are controlled and distributed properly according to established procedures.
Oversees the Nonconformance and Corrective/Preventive Action systems. Ensure timely closure of all non-conformances, failure investigation reports and corrective/preventive actions (CAPA) and in accordance with the established guidelines and database systems. Work in conjunction with other internal departments and external customers as appropriate, ensuring that the executive management is informed of serious complaints or issues that impact the organization.
Oversees the Supplier Monitoring program including supplier assessment and corrective actions. Provides input to QC inspector and Purchasing/Planning departments related to supplier performance and actions to be taken. Leads periodic review of supplier performance and develops supplier audit schedule. Performs supplier audits as designated in the schedule. Trains other individuals on supplier auditing, as necessary.
Performs internal audits of company departments and vendors, as necessary, to ensure compliance to regulations. This includes potential to perform internal audits of other sites within the diagnostic division.
Acts as a support for customer and regulatory audits; Has the ability to understand and interpret ISO 13485 standards and other applicable regulatory standards.
Analyze and present related reports, data and Key Performance Indicators for management and executive review as requested. Provides insight into trends observed and conclusions from the data.
Provides Quality input in Complaint meetings and investigations.
Leads teams and/or investigations as necessary to accomplish goal and quality objectives. Provides training and coaching to personnel within and outside the Quality departments on company policies, established protocols, etc. as necessary.
Knowledge, Skills and Abilities Required:
Ability to show initiative and to perform in a multi-task environment.
Good interpersonal and verbal/written communication skills.
Managerial skills and ability to lead teams.
Ability to work with personnel of all levels.
Knowledge of QSR and ISO.
Technical writing capability.
Education and Experience:
Undergraduate degree in a biological-based science preferred or minimum of 5 years Quality Assurance, Q
To apply please email your resume to email@example.com
Thank you for applying to the Quality Assurance Manager position. Your job application has been routed to the appropriate branch for consideration.
Please make note of your Password, as you will need this if you are selected to move forward in the process.
Your email address will most likely serve as your username.