Decision-making and problem solving.
Planning and Organization
Teamwork and people development
Oral communication skills
Education : University Degree : B.Sc. Engineering or similar
Experience : No applicable
Specialized Knowledge (desirable) : People Management (must), Statistics, Problem Solving, Process Improvement, Risk Management, CFDR 820
Languages : English
Tools : Minitab, Visio, Gantt Chart
Summary of Dutties & Responsabilities
Lead the Quality Control group to ensure the in process components / subassemblies and finished goods meet the approved specifications before being accepted.
Support and promote the implementation of EHS programs to ensure people safety and environment health.
To provide the necessary resources for the Quality Inspectors so they can perform their duties as intended. Review and weekly update, the attendance and the actions on the payrol system, with the goal of paying on time to his / her personnel in charge.
Plan and maintain the goals for the Quality Inspectors team (performance card) to foster quality at the sources and operational excellence mind set.
Recruit along with Human Resources Department, personnel for the Quality Control dpt, as per the corresponding pre-defined job description.
Lead and supervise all the quality related activities with the productive areas (CER, Non-CER and satellite) and balance the amount of existing work to comply with the goals stablished by the organization.
Lead and execute tools such as : one on one meetings, recognition based on results, positive confrontation, effective listening, situational leadership, among others, to foster an adequate work environment.
Lead and / or coach Quality Inspectors on applicable regulations and on quality criteria linked to procedures and specifications.
Lead, develop, control, analyze and communicate metrics on Level 2 meetings, to foster operational excellence among current processes, as well as in the introduction of new products and transfers, to guarantee the compliance of strategic goals stablished by the organization.
Review and approve if applicable, quality figures such as, INV, NCEs, Change orders, etc.
Work in a collaborative manner with the Quality Engineering team, for the implementation of Quality tools in the production floor, such as : Advanced Product Quality Planning, Statistical Process Control, Switching rules, etc
Participate (as needed) in containment meetings or on any other applicable follow up meeting, to gurantee compliance around applicable regulations / product specifications.
Support as needed, internal and external audits from Regulatory entities and Notified Bodies to guarantee the commercial distribution of products manufactured by Costa Rica facility.
Support NPIs and transfers, ensuring compliance in the productive areas.
Ensure that Investigations, such as EIR, CAPA, IACA, and similar, are performed on time, in compliance with procedures and regulations.
Maintain and control KPIs and other metrics.
Resources administration& Personnel administration
Maintain, improve and simplify procedures, processes and methods
Ensure collaborators are in compliance with regulatory training.
Promote development of talented people and collaborators’ engagement.
Provide adequate technical support regarding Quality Control issues through the proper interpretation of specifications, acceptance criteria and regulations in order to resolve issues MFG processes,due to assignable causes or system issues, and therefore assisting in the identification of root causes and contribute ideas to resolve such issues.
Maintain ongoing communication with all CSPO members (local and / or extended) in order to facilitate the decision making process that impacts product, manufacturing line and / or project performance.
Assist on the investigation of product failures, customer complaints, rejects and failures detected in order to establish adequate preventive and corrective actions.
Ensure proper segregation, identification and disposition of materials of non conformances under his / her responsibility.
Review and update documentation under the responsibility QA and elaborate new documentation and procedures to ensure the continuous improvement of the quality system.
Review and approve change orders and / or protocols, and reports to ensure the adequate implementation of production processes and systems.
Provide information to Management for the planning of yearly targets and processes.
Promote and / or support the use of quality and statistical tools for the various activities performed and / or supported by the Quality Engineering Area
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