Offerta di lavoro
Coordinatore Controllo Qualità Ispezioni Visive
Medtronic
Publicato il 05/09/2023
Scope of the position:
The scope of the position is to coordinate and manage the quality control operators dedicated to production process control in the manufacturing of dialyzers. The team is made of 5 quality control operators working in 24/7 shifts. The most part of the daily job takes place in a cleanroom environment.
The person will work in normal daily office work hours but occasionally could be asked to backup operators in case of their unexpected absence.
The person will report to the Quality operation manager disposables.
The core of the position is collect/receive inputs from quality control operators referred to quality problems detected in production, analize data, give direction for immediate containement actions, corrective actions. If appropiate execute tests or coordinate the execution of test to verify the identified defects root causes
Escalate quality issues to Non conformity and eventually ask for the opening of a CAPA
Responsibilities:
Responsibilities may include the following and other duties may be assigned:
Uses predetermined methods, operations, setups and prescribed specifications to inspect visually in-process and completed products directly or delegating the process control operators. Uses various complex measuring devices and testing equipment: analogic, digital, programmable.
Accepts, rejects, or reworks defective or malfunctioning units or systems.
Takes decisions on the acceptability of products identified and segregated as defective in compliance with company procedures and instructions. Authorization to deviate to product/process technical requirements is not among the role authorities and responsibilities.
Works from blueprints, diagrams, dial indicators, preset micrometers, scales, fixtures, customer specifications, drawing or inspection instructions and checklists.
May monitor and verify quality in accordance with statistical process or other control procedures.
Define in process control methods and instructions in collaboration with manufacturing engineering team.
Is responsible for issuing the process control instructions and specifications
Provides primary input to hiring, firing, promotion, performance and rewards decisions for direct reports.
Execute and support internal and external quality audit.
Has a leading role in the PFMEA(Process Failure Mode and Effect Analysis)team.
People Management:
Management and supervisory professionals with more than one employees who are focused on tactical, operational and some strategic activities within the in process control area. The majority of time is spent overseeing the direct reports area of responsibility, managing performance, developing talent, engagement and inclusion, communicating business and operational developments, planning, prioritizing and / or directing the responsibilities of direct reports. Goal achievement is typically accomplished through performance of direct and / or indirect reports. A key responsibility of roles in this career stream is managing people. which includes: accountability for mentoring, developing and coaching staff on meeting/exceeding performance expectations and defined objectives, providing leadership to staff ensuring the prioritization of strategic and department level initiatives to include defining performance goals and targets, conducting performance reviews, and staff 1:1s to guide performance management and employee development efforts and manage toward departmental goals.
Differentiating factors:
Autonomy: Supervises team members providing tactical and / or technical supervision.
Spends a portion of time performing individual tasks.
Receives assignments in task-oriented terms and delivers results according to established procedures.
Organizational Impact: Plans operational objectives for the Process Quality control team.
Decisions impact team schedules or the allocation of time or material resources.
The position does not have budget or P&L accountability, but may manage day-to-day elements of the budget (eg, overtime for staff, materials).
Innovation and Complexity: Makes adjustments or recommends enhancements in systems and day-to-day department processes.
Problems and issues faced may not be defined, and may require understanding of broader sets of issues.
Communication and Influence: Communicates with internal and external customers and vendors.
Shares and exchanges relevant information to reach solutions.
Typically presenting information and exchanging information .
Provides day-to-day work direction for team, focused on maintaining steady workflow, resource allocation and productivity.
Required Knowledge and Experience:
Understands basic management approaches such as work scheduling, prioritizing, coaching and process execution.
Requires broad job knowledge of technical or operational practices within quality control operations(medical device, pharma, cosmetic or food preferably ) in complex and highly automated manufacturing environment.
Three years experience is required,
Requires a Baccalaureate/Master degree in Engineering(biomedical/mechanical/electronic) or Chemistry, CTF, Physics.
Preferably Green belt certification.
Expert in use of investigation tools(Ishikawa, 5 whys…)
Knowledge of quality standards (ISO13485:ISO9001)
Good knowledge of English language is required (B2).
About Medtronic
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.
We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.
Physical Job Requirements
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)
Additional Information
Posting Date: Mar 31, 2021
Travel: No
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