Supplier Quality Engineer

Description:

Company Overview

Biomerics is a world-class manufacturer and innovative polymer solutions provider for the medical device and biotech industries. As a vertically integrated company, we specialize in designing, developing, and producing medical devices for diagnostic and interventional procedures. We are focused on next-generation solutions for vascular access, electrophysiology, cardiac rhythm management, neurovascular, structural heart, and cardiovascular markets.

At Biomerics, we are dedicated to our diverse employee base. We understand that a strong, skilled, and engaged workforce is the foundation of our continued success as a business. We strive to live up to the Biomerics values in all our interactions. It is an exciting time to be part of our collective team, and there is no limit to the impact that can be achieved here at Biomerics. We improve and advance the lives of our employees and patients who depend on our products.

At Biomerics, we believe in integrity, partnership, empowerment and accountability, trust, agility, teamwork, and excellence, and we care. Our team-oriented, customer-focused corporate culture prioritizes building strategic, mutually beneficial partnerships with customers and our team members.

Job Description

A Supplier Quality Engineer is responsible for ensuring the quality of products received from external suppliers by conducting thorough audits, identifying and resolving quality issues, working closely with procurement and engineering teams to implement corrective actions, and maintaining strong relationships with suppliers to continuously improve product quality and compliance with company standards You will serve as a Quality representative to improve awareness, visibility, communication on quality initiatives to support departmental, functional, site, divisional, and corporate quality goals and priorities. You may support new product development (NPD) as needed. As the Supplier Quality Engineer, you will lead Quality Assurance (QA) in support of manufacturing activities in accordance with the requirements of USFDA CFR 820, ISO 13485, and MHLW Ministerial Ordinance 169.

Job Responsibilities

• Supplier evaluation and selection: Assessing potential suppliers through audits and reviews to ensure they meet quality requirements and capabilities.
• Quality system oversight: Monitoring supplier quality management systems to verify compliance with company standards and industry regulations.
• Supplier audits: Conducting on-site audits at supplier facilities to evaluate manufacturing processes, quality control procedures, and documentation.
• Quality issue identification and resolution: Analyzing incoming materials and products to detect defects, performing root cause analysis, and working with suppliers to implement corrective actions.
• Process improvement: Collaborating with suppliers to identify opportunities for process improvements and implement solutions to enhance product quality.
• Technical support: Providing technical expertise to suppliers regarding product specifications, quality standards, and testing methods.
• Advise and support Quality Inspectors on day-to-day issues with incoming materials.
• Documentation and reporting: Maintaining detailed records of supplier performance, quality issues, corrective actions, and audit findings. Create, issue, and complete Supplier Corrective Action requests.
• New product introduction support: Working with the engineering team to ensure new suppliers and components meet quality requirements during product development.
• Supplier performance monitoring: Tracking key performance indicators (KPIs) to evaluate supplier quality and identify areas for improvement.

Requirements:

Education / Certifications

• High School Diploma or GED required
• ASQ / CQE certifications
• Six Sigma Certified Green or Black Belt

Job Requirements

• Strong understanding of quality management systems (QMS) and industry standards.
• Working knowledge of FDA QSR (21 CFR Part 820), ISO 13485, MDD/AIMDD, CMDR, JPAL medical device regulations; Ability to understand other medical device regulations and standards.
• Experience with statistical analysis tools (e.g., SPC) to identify trends and root causes.
• Excellent communication and interpersonal skills to effectively collaborate with suppliers and internal teams.
• Ability to conduct thorough audits and assessments.
• Problem-solving and analytical skills to identify root causes and implement effective solutions.
• Proficient in data analysis and report generation.
• Minimum of 5 years’ experience in Quality Engineering within a Medical Device Manufacturing environment.
• Experience in nonconforming material and CAPA methodologies/systems preferred.
• Familiar with Microsoft Office Suite and Minitab Statistical Analysis software (or equivalent).
• High sense of urgency and commitment to execution.
• Applies continuous improvement principles in the development of the quality system.
• Driven, energetic, self-assured professional with high personal integrity.
• Knowledge of analytical techniques and statistical analysis.