Supplier Quality Engineer

Pioneering trusted medical solutions to improve the lives we touch: Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in advanced wound care, ostomy care, continence care and infusion care. With around 10,000 colleagues, we provide our products and services in almost 100 countries, united by a promise to be forever caring. Our solutions provide a range of benefits, from infection prevention and protection of at-risk skin, to improved patient outcomes and reduced care costs. Convatec’s revenues in 2023 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more about Convatec, please visit  http://www.convatecgroup.com

Responsibilities:

Development of the supplier quality system

Participate in the supplier audits for new and existing suppliers as per schedule and the appropriate level of documentation as per procedure.

Handle the non-conformities/SCARs and Corrective/Preventive actions when escalated, on timely manner.

Participate on Supplier Quality Reviews in collaboration with Category Managers Active participation on Material Review Boards (MRB)

Participate on the approval of new suppliers as per procedure.

Assure the supplier evaluation are performed and take actions accordingly. Responsible for immediate communication and the follow up on final disposition of raw material (no conformance, acceptable materials, etc.) in adequate time and according with approved procedures.

Participate on root cause analysis, NC reviews, analysis of FMECA's, coordinate investigations, etc. if required.

Manage QA/QC related activities in relation to new and existing tools approval processes.

Drive continuous improvements in relation to total cost ownership, speed, optimization etc by use of known LEAN techniques in collaboration with supplier and stakeholders.

Actively participate in various new product development, product transfer and other optimization projects

Promote teamwork among his area, and other areas.

To comply with the company quality policy.

Follow up, development, and compliance according to the Quality Management System based on the regulations and standards of ISO 13485, FDA, GMP, MDR.

Requirements:

Bachelor’s degree (Industrial area or similar), required

Three years as Supplier Quality areas experience, preferred

Measurement equipment knowledge skill preferred.

Written and spoken English required

Internal Auditor required

Experience of quality tools, statistic techniques (SPC, etc.) preferred

Software utilization skills / Computer skills required

Ability to coordinate multiple projects, projects planning and work cohesively with all involved departments

General knowledge of injection molding processes preferred. Familiar/knowledge on ISO 2859-1 (AQL values and sampling plan) Familiar/knowledge on basic requirements of FDA QSR's GMP's and ISO 13485, MDR or similar regulations, required.

Internal training

Compliance with document 4902900

Induction to ISO 14001:2015.

Induction on Environmental Legal Requirements, Training on Applicable Environmental Management System Documents, Disaster Care and Response, Applicable Operational Controls, Determination of Applicable Significant Environmental Aspects and Impacts, EHS Policy and Environmental Objectives.

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Convatec provides equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, gender identity, military or veteran status, genetic predisposing characteristics or any other basis prohibited by law.

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