Supplier Quality Engineer

Job Description
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.
 
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.
 
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
 
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.
 
Industry Type-Pharma, Biotech, Clinical Research
Functional Area-Production, Manufacturing, Maintenance
Employment Type-Full Time, Permanent
Role Category-Production/Manufacturing/Maintenance
 
Education
UG : Diploma in Mechanical
PG : Post Graduation Not Required


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