Incoming Engineer, Quality
Cardinal Health
Alajuela, Alajuela, Costa Rica
hace 5 días

What the Incoming Quality Engineer contributes to Cardinal Health

Manages the activities of the Incoming Quality Control department to ensure incoming raw materials, components and manufactured products meet their approved specifications or other regulatory requirements.

Lead and manage the Incoming Quality Lab. Define the roles and responsibilities for the Incoming Quality Techs as define the priority for Incoming inspections.

Also, it is responsible to resolve any inconsistency and / or problem in the Incoming area. Lead and assure the control of incoming issues and nonconformance material.

Work in the evaluation of the effectiveness of suppliers and their materials towards established requirements and develop a team approach for addressing any deficiencies.

Identify, evaluate and execute opportunities for continuous improvement consistently. Position is expected to function as a problem solver, capable of analyzing problems and implementing root cause elimination solutions.

Position maintains primary focus factory responsibility for critical quality systems including the internal audit program, CAPA system, and control of non-conforming product

Accountabilities

Ensures department personnel conduct inspections according to approved procedures / specifications.

Ensures Incoming Inspection Department compliance according to procedures, standards, and regulations.

Get involve in various stages of equipment, product changes, new product development and processes validations : Run and / or review and / or approve reports IQs, OQs and PQs as well as any other document relating to the laboratory validations.

Coordinate and lead new projects related to cost savings and process improvements. Interface cross-functionally to ensure timelines and concepts meet business requirements.

Responsible for meeting and reporting all the metrics as applicable; proactively seek ways to support the focus factory core teams.

Work closely with Purchasing, Engineering, Supplier Quality and Manufacturing to establish the corrective action plans to meet the requirements of the full product lifecycle.

Interacts with internal and external customers, by meeting regularly, responding to requests and explaining procedures.

Promote a safe work environment by ensuring the highest standards in employee safety.

Promote communication and teamwork across shifts / crews / sites as applicable.

  • Provide direct and ongoing leadership for Incoming Control Technicians. Supervise, train, and develop technicians according to the applicable policies, standards and regulations;
  • develop goals / objectives for all assigned personnel; monitor employees' performance against goals, provide performance feedback and mentoring;
  • write and conduct development plans / performance appraisals; manage employee HR issues.

    Tracks the status of incoming materials and keeps QA Organizations and other appropriate departments informed of inspection status.

    Conducts quality investigations for non-conforming product and recommends corrective action / preventative action (CAPA) plan.

    Responsible of NCR generated during the Incoming Inspection and the necessary actions to involve other areas and ensure timely closure.

    Comply with statutory responsibility under the national or federal regulations such as taking reasonable care of his or her own safety, health and welfare and of any other persons who may be affected by his or her acts or omissions at work.

    Follow established EHS procedures and policies.

    Encourage coworkers to follow EHS procedures.

    Participate in employee engagement activities such as EHS inspections and EHS meetings

    Report EHS incidents and hazards, assist in root cause analysis as appropriate, and cooperate in finding solutions or implementing improvement.

    Complete required EHS training.

    Qualifications required

    University studies in Industrial, Chemical, Mechanical Eng. or similar.

    ASQ CQE certification is desired.

    3-5 years experience in a medical device manufacturing environment, preferably in Engineering or QA Technician.

    English : Advanced proficiency

    Computer skills including statistical / data analysis.

    Quality System Standards, GMPs and Regulations experience is desired.

    Project Management, SPC, DOE, FMEA, CAPA, internal audits, process validations, complaints system, root cause analysis, risk analysis techniques, capability studies knowledge is desired

    What is expected of you and others at this level

    Applies working knowledge in the application of concepts, principles, and technical capabilities to perform varied tasks

    Works on projects of moderate scope and complexity

    Identifies possible solutions to a variety of technical problems and takes actions to resolve

    Applies judgment within defined parameters

    Receives general guidance may receive more detailed instruction on new projects

    Work reviewed for sound reasoning and accuracy

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