Qualification Required

• BS Degree in Manufacturing Engineering, Mechanical Engineering, Industrial Engineering, or a related field required.

Roles And Responsibilities

The Manufacturing Quality Engineer will play a key role in supporting existing processes for the casting of medical device components.

• Revises / analyzes if the current products and processes (including taken actions or decisions) comply with the regulations, such as QSRs, ISO 13485, etc. including providing support during internal and external audits.
• Participates in the preparation’s activities for/or interactions with regulatory agencies (FDA, JJRC, BSI, etc.).
• Responds to internal or external audit observations related to the quality engineering function.
• Properly establishes and maintains the required documentation of quality assurance activities and/or quality systems.
• Performs periodical audits to the line to evaluate GMPs, production controls, lot segregation and process audit according to JJPS. Checks the audit results of the area to ensure that the corrective and preventive actions are adequate.
• Works with NPI and with the manufacturing, process engineering and manufacturing engineering departments to develop, conduct and approve product and process validation strategies of products and processes.
• Directs and attends to NCs Revisions meetings as a member of MRB.
• Conducts and supports investigations, bounding, documentation, revision and approval of the non-conformities (NCs), preventive and corrective actions (CAPAs) and customer complaints. Escalation of quality problems when applicable.
• Provides support in the analysis of products related to customer complaints, to determine failure modes.
• Analyze / check the effectiveness of preventive and corrective actions.
• Defines sampling plans and approves inspection methods for evaluation and acceptance of components and finished product.
• Provides support in the resolution of complex problems (technically) associated with the manufacturing process to a local or franchise level.
• Revises, approves, executes IQ, OQ, PQ, TMV or Software Validation.
• Maintains and periodically revises the CTQs in the manufacturing process to guarantee the continuous satisfaction of the customer.
• Develops, maintains and checks that the measuring methods are appropriate for the manufacturing processes.
• Provides support in the revision and maintenance of PEMEAs, Quality control plans, process instructions and additional manufacturing documents.
• Develops, interprets and properly implements process monitoring and control methods consistent with the process/product risk level.
• Evaluates and interprets common variation causes vs special in the manufacturing process and determine the adequacy of the current process limits.
• Evaluates the need of risk mitigation techniques given product classification, potential types of defects, defect frequency, severity, risk for the patient, process capacity, process controls, etc. Determines the effectiveness of these techniques in the previously implemented improvements.
• Responsible and owner of the risk assessment process including the realization, documentation, revision or maintenance of the current risk and documentation of the risk assessment such as FMEA of the process given the changes in the product/process.

Required Technical And Professional Expertise:

EU-MDR, Quality System Requirements (QSR), Gage R&R, ISO 13485, IQ/OQ/PQ, CTQ, Lean Manufacturing, Six Sigma, inventory optimization, Production NC, CAPA, Regulatory Requirements, Verification & Validation, Medical devices Engineering change process, Medical Devices Quality Management, Design controls, problem solving skills, etc.