Supplier Quality Engineer

Rhian_Convatec; United States; Remote; USD 60,000 - 100,000; Full time

Job summary

An established industry player is seeking a Supplier Quality Engineer to support strategic projects in enhancing their Global Supplier Quality program. This pivotal role involves maintaining supplier performance metrics, conducting audits, and ensuring compliance with medical device standards. The ideal candidate will have a strong background in the medical device industry, with experience in quality control processes and supplier management. Join a team dedicated to improving patient outcomes through innovative medical solutions and enjoy the opportunity to make a significant impact in a dynamic and supportive environment.

Qualifications

• Minimum 3 years in the medical device industry required.
• Experience in Supplier Quality Control and leading audits is essential.

Responsibilities

• Support and enhance the Global Supplier Quality program.
• Conduct supplier audits and manage quality relationships globally.

Skills

Medical Device Industry Experience

Supplier Quality Control

CAPA/NC/SCAR Initiation

Supplier Audits

ISO13485 Knowledge

Statistical Skills

Electronic Databases

Microsoft Word

Microsoft Excel

Microsoft Visio

Education

BS or higher in Science or Engineering

Quality Auditor or Lead Auditor certification

Tools

Documentum

Trackwise

SAP

Job description

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 Convatec Group.

The role:

The Supplier Quality Engineer supports complex and strategic projects which maintain and enhance the ConvaTec’s Global Supplier Quality program.

Key Responsibilities:

• Support the maintenance and improvement of ConvaTec’s Global Supplier Quality program.
• Focus on establishing, maintaining, and improving supplier performance metrics, policies, and procedures in administering quality relationships with suppliers globally.
• Investigations relating to suppliers’ issues through the SCAR and CAPA process.
• Internal Investigations through the NC and CAPA process.
• Support and lead where appropriate, supplier selection, evaluation, and approval.
• Conduct Supplier audits.
• Generate and monitor appropriate key performance indicators to assess supplier performance in a timely manner to drive resolution of corrective actions from the suppliers.
• Raise appropriate questions or concerns regarding regulatory compliance to appropriate authorities regarding Purchasing Control activities.
• Demonstrate high commitment to quality and customer service based upon customer needs.
• Build strong relationships with customers, suppliers, stakeholders, and support groups worldwide to meet the demands of a changing business environment.
• Demonstrate technical knowledge and principles in relation to medical devices in line with ISO13485 ISO9001 GMP Parts 201 and 211, EU MDR.
• The employee may be required to perform other duties as assigned by management or supervisors that are reasonably related to the job or necessary for the smooth operation of the organisation.

Skills & Experience:

• Minimum 3 years of experience in the medical device industry.
• Minimum 2 years of experience in Supplier Quality Control.
• Experience in internal and supplier related CAPA/ NC/ SCAR initiation.
• Experience in supplier onboarding and quality agreement creation.
• Experience in leading supplier audits at manufacturing sites.
• Experience in supplier monitoring.
• Knowledge of ISO13845 and FDA medical requirements.
• Statistical skills.
• Strong prioritization and coordination skills.
• Ability to work with electronic databases (i.e. Documentum, Trackwise, SAP).
• Advanced computer management skills including Microsoft Word, Excel and Visio.
• Proactivity and flexibility to meet priorities and achieve deliverables.
• Ability to negotiate and partner with internal and external customers to enhance operational effectiveness.

Qualifications/Education:

• BS or higher degree qualified in Science or Engineering.
• Quality Auditor or Lead Auditor certification is preferred in ISO9001 or ISO13485.

Remote, presence at the local office may be required based on in-country legal requirements and for specific meetings/ projects/ events.

This is work that’ll move you.

Equal opportunities

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.