Incoming Supplier Quality Leader

Job Summary
The Sr Leader QE is responsible for the Supplier Quality management process, including the qualification, maintenance/evaluation, development, and discontinuation of suppliers.Is the supervisor of the incoming inspection department, assuring that the operations and inspections are performed according to the QMS.Also, support the Quality Engineering, process and validation team in their daily task.
Job ResponsibilitiesResponsible to maintain the Supplier Quality Management for the DR site.Responsible to maintain and control Incoming activities.Supervise Incoming Quality Inspectors.Ensure action plans resulting from the audit processes for Supplier Quality and Incoming.Ensure Supplier Quality and Incoming metrics are maintained, and trends are analyzed, as applicable.Ensure statistical methods are applied to Supplier Quality and Incoming evaluations, problem-solving and improvement.Ensure investigations are perform and documented on non-Conformities presented in Supplier Quality Management and Incoming, as applicable.Responsible to Validate Quality equipment’s, as applicable.Develops new approaches to solve known problems.Assist in the compliance and maintenance of standards (e.g., FDA, ISO 13485), Quality policies and procedures.Raise any evidenced non-Conformity to the Staff.Complete assigned tasks in a timely manner.
Functions described include most of the key responsibilities related to the position, but it is not limiting and can be modified at any time. In addition, you must follow instructions and requests related to your duties by your immediate supervisor.
Education and ExperienceBachelor’s degree in engineering discipline or equivalent.Minimum of 5 years’ experience in Quality Control in a regulated industry with detailed knowledge of industry processes and practices.Minimum of 5 years’ experience in supervision of Receiving and Work In-Process supervisors and inspectors.Familiarity with regulatory requirements (FDA 21CFR820, ISO 13485:2016).
Knowledge and SkillsDetail oriented.Organized and management time efficient.Strong analytical ability and objectivity in making recommendations and decisions.Good interpersonal skills.Advanced knowledge of Office package.Advanced English writing, reading, speaking, and listening skills.Knowledge of Cleanroom environmental requirements and testing methodologies for those requirements.Knowledge of ISO 13485, ISO 9001, and other Quality System Standard.Knowledge or experience of auditing to ISO requirements.Personnel supervision.Knowledge of lean and six sigma tools.Familiar with Document Control or Quality Management System Software including Management System Software and inventory and warehouse management software.Good verbal and written communication skills, with demonstrated ability to generate technical reports, and ability to make presentations to middle and upper management.
Physical DemandsRequires moderate time standing, sitting or in constant movement.Lift loads up to 10–50 lbs.Use of hands and fingers to grip samples and measuring instruments.Availability for domestic and international travel.
Work EnvironmentAbility to work as an independent contributor and in a team.Ability to work inside temperature control room, labs, and warehouse.Ability to work extended hour occasionally or on demand.