Job Description

Be a part of a global team where what we do matters!At Epredia, we recognize that our talented employees are vital to our success. Our team is dedicated, our work is rewarding – both personally and professionally – because what we do matters. 

We seek talented individuals who will contribute to and thrive in our collaborative, diverse, fast-paced environment while demonstrating a commitment to our core values, People, Customer, Results, Continuous Learning, and Innovation. 

People – We win as a team. 

Customer – We deliver customer-centric solutions. 

Continuous Learning – We learn and always aim to be better. 

Innovation – We innovate every day. 

Results – Results matter for all of us.

Job Title: Senior Supplier Quality Engineer

The SQE will establish a supplier audit schedule based on sound risk-based methodology, and conduct supplier audits according to the schedule or based on need.

Key Responsibilities:

• Manage the supplier quality program including, but not limited to, supplier selection and approval, supplier performance monitoring, supplier change notifications and supplier corrective actions.
• Support supplier selection and approval by performing quality & compliance assessments/audits of proposed new suppliers and ongoing monitoring of existing suppliers.
• Monitor supplier performance (KPI’s) through regular communication, frequent reporting and follow-up.
• Track, trend and communicate supplier quality metrics providing input to periodic Supplier Performance Monitoring meetings and Management Reviews.
• Act as Lead Auditor during supplier audits. Ensure management of supplier audits from planning to completion.
• Participate in design changes related to supplier provided materials. Coordinate the preparation of quality test/inspection plans (including design verification & validation) for proposed new components and/or existing components from a new supplier.

Minimum Requirements/Qualifications:

• Bachelors Degree in mechanical engineering or technical discipline or an equivalent combination of education, experience and/or licensure/certification.
• The required skills, knowledge and abilities that are typically acquired through a minimum of 10 years in supplier quality assurance.
• Knowledge of overall regulatory requirements associated with medical products into worldwide markets.
• Experience and knowledge of ISO13485/ GMP/ FDA 21 Part 820 requirements with particular focus of supplier controls and supplier performance management, and the ability to apply the knowledge to the business to ensure compliance to the regulations.
• Lead auditor training required, Lead Auditor certification (CQA/ASQ/ISO) is preferred.

TO ALL RECRUITMENT AGENCIES:Epredia does not accept unsolicited third-party resumes.

Building an Inclusive Culture: We are a company that brings the best people together and leverages their varying backgrounds, ideas, and points of view to invent on behalf of all customers. We are committed to equal employment opportunity for all individuals, without regard to race, color, national origin, ancestry, sex, age, religion, physical or mental disability, medical condition, veteran status, marital status, pregnancy, sexual orientation, gender identity, genetic information or any other protected classes which may exist under applicable federal, state or local law.