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| Roles and Responsibilities |
| Responsible for ensuring that the products produced meet quality standards required to minimize quality costs and maximize customer satisfaction while ensuring that procedures and processes are adhered to. |
| Ensure incoming materials meet required quality standards. |
| Responsible for identifying and raising quality issues and for speedily resolving them to ensure zero impact to the customer. |
| Support new product introductions to ensure the robustness of product builds. |
| Work in a team environment to develop and implement best practices that emphasize defect prevention, reduction in variation and waste and provide for continuous improvements in meeting all customer requirements. |
| Manage the customer specific requirements and offer technical support. |
| Responsible for multiple highly complex major projects requiring innovative original solutions where results are key to successful completion of major projects. |
| Work mostly independently with minimal supervision and work is reviewed at project milestones and/or on completion by Senior Management. |
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| Functions: |
| Implement FMEA/riskbased incoming inspection processes and lead quality at the source initiatives. |
| Systematically monitor risk in supply chain through the vendor approval process, onsite assessments, and supplier metrics. |
| Communicate quality issues to suppliers and the value stream through proactive relationships. |
| Evaluate proposed changes at suppliers and support change management. |
| Design and/or specify inspection and testing procedures/systems |
| Lead the supplier corrective action process (SCAR) and investigate/analyses inhouse and field failures (complaints) and improve product quality by determining root cause and recommending corrective actions. |
| Propose, recommend, and oversee implementation of component and process improvements based on quality trends. |
| Participate in investigation and analysis of customer complaints and field service trends. |
| Review and approve disposition for Nonconforming Product and support Material Review Board (MRB). |
| Lead efforts to continuously improve product quality, while ensuring safety, efficacy, and regulatory compliance. |
| Will work collaboratively with Engineering, Production Engineering, and Supply Chain to understand the design and production impacts in order to determine dispositions of nonconforming material. |
| Support all functional departments to ensure compliance with Quality System and lead continuous improvement efforts of the Quality System. |
| Be key participant in CAPA Committee and any Data Review Committees. |
| Closely partner with Purchasing/Planning commodity teams and interface with personnel from all areas of the company to foster improved quality and efficiency. |
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| Core Skills Competencies: |
| Exercise substantial initiative/judgement in work methods and interpreting goals |
| Work independently and is reviewed infrequently with minimal supervision |
| Self-supervising within the guidance and expectations of divisional management |
| Knowledge of quality systems and measurement |
| Lean Manufacturing knowledge |
| Knowledge of ISO 9001:2015 and ISO 13485:2016. |
| Understanding of engineering and manufacturing processes |
| Ability to work in a diverse and dynamic environment |
| Planning and prioritizing activities |
| Good communication and interpersonal skills |
| Negotiation skills |
| Ability to present data effectively |
| Problem-solving skills |
| Team working skills |
| Analytical skills |
| Understanding of cost and financial impacts |
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| Qualifications and Experience Levels: |
| Engineering degree / Diploma in Electrical and Electronics |
| Minimum of 5 years of experience in a quality assurance, engineering, or manufacturing environment for supplier performances. |
| Previous experience in a high volume manufacturing environment. |
| Preferably from Consumer products, Hygienic Clean environment. |
| Familiarity with manufacturing processes for electro-mechanical devices including final assembly and test, SMT, printed circuit board assembly, extrusion, casting, metal stamping, injection moulding, painting, coating, and plating. |
| Six Sigma/Lean Manufacturing skills |
| Experience of dealing with customers and suppliers |
| Previous audit experience. |
| Ability to understand complex manufacturing issues and drive suppliers towards resolution. |
| Knowledge of quality assurance processes, especially corrective action (8D) and root cause analysis. |
| The ability to manage projects and track multiple critical issues. |
| Excellent interpersonal and team leadership skills. |
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| Industry Type-Pharma, Biotech, Clinical Research |
| Functional Area-Production, Manufacturing, Maintenance |
| Employment Type-Full Time, Permanent |
| Role Category-Production/Manufacturing/Maintenance |
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| Education |
| UG : Diploma in Mechanical |
| PG : Post Graduation Not Required |
