Job Detail

Supplier Quality Engineer (604069)

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Requisition Number

EMEA07385

Employment Type

Full-time

Location

Geneva

Job Summary

The Supplier Quality Engineer is responsible for ensuring that all steps are taken to provide the highest quality products to Zimmer Surgical customers’ .The SQE will support the overall Supplier Quality Management. This position must drive incoming quality by evaluating new and existing suppliers and resolving supplier issues to closure in a timely manner. The SQE will provide supplier qualifications, material qualification, material issue resolution, driving supplier corrective actions, and maintain the approved manufacturer list. The SQE will perform Audits Suppliers per compliance with regulatory and corporate requirements. The SQE participates in new product development and process improvement teams and formulates quality assurance policies and procedures dealing with Suppliers.

 

Principal Duties and Responsibilities

Audits:

 

• Carrying out external system and process audits at suppliers;

• Carrying out audits (product, desktop, qualification);

• Following-up of Supplier Corrective Actions and reporting related metrics;

• Following-up regulatory and corporate requirements;

• Assisting project teams within the organization on quality related issues.

 

Supplier Quality Engineer:

 

• Manages and monitors implementation and effectiveness of corrective actions related to NCR findings;

• Manage the supplier audit plan;

• Assists suppliers in developing strategies for corrective action and preventive action;

• Identifies risks to products and processes that trace to deficient quality systems, uncontrolled critical parameters, changing regulatory requirements, and changing technical requirements;

• Collects and analyzes quality metrics from various quality systems and develops reports as needed for KPI, Management and SRB review. Provides recommendations based on trends;

• Collaborates with Sourcing to track ongoing supplier quality performance and work with suppliers on quality issues;

• Approve supplier selection through robust qualification processes; Manage the ASL update

• Lead qualification of new product introduction according to Supplier Production Process Approval procedure

• Develop positive relationships and work closely with Global Supplier Management to manage and implement supplier changes, New Product Introductions;

• Lead and assist project teams within the organization on supplier quality related issues;

• Member of Material Review Board;

• Ensures that all Corporate Quality Procedures SQ relevant are implemented and maintained within GVA QMS. Member of Supplier Review Board.

 

Expected Areas of Competence

• Ability to read and interpret drawings;


• Broad knowledge of regulatory requirements (FDA / ISO 13485 / GMP …);


• Experience in interpreting and applying regulations and standards, auditing to these standards and processes good oral and written communications abilities;


• Understanding of all engineering fields and internal processes to be audited;


• Familiar with a variety of office software packages including MS Word, Power Point, Visio, Excel, SAP and MS Project etc..;


• Good report, business correspondence & procedure-writing skills;


• Ability to be Issue Evaluation and Capa task owner;


• Knowledge of production and business processes;


• Details and in depth analysis.


• French: Native Language or fluent;


• Good problem-solving ability and analytical skills, strong sense of initiative, follow-through and attention to detail;


• Excellent interpersonal skills /intercultural impact;

Education/Experience Requirements

• Position requires a sound technical background (university degree, technical degree or equivalent of technical nature);


• Auditor training with Diploma examination (SAQ or equivalent) preferred.


• Experience in manufacturing industry (preferably medical devices or pharma) and in a quality organization.

Travel Requirements

Up to 40%

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