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 Quality Engineer is responsible for providing Quality Engineering input to support Medical Device Manufacturing, Manufacturing Engineering, Operations, and Distribution activities. The QE will develop, establish, and maintain quality engineering methodologies, systems, and practices that meet Biomerics, customer, and regulatory requirements. You will serve as a Quality representative to improve awareness, visibility, and 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 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.

Job Responsibilities

• Lead Quality Assurance in support of manufacturing activities in accordance with the requirements of USFDA CFR 820, ISO 13485, and MHLW Ministerial Ordinance 169.
• Manage validation activities as established by USFDA CRF 820, ISO 13485, MHLW Ministerial Ordinance 169, and other regulatory bodies as required.
• Support engineering efforts by developing, implementing, and maintaining quality requirements and standards throughout the design transfer and manufacturing of products.
• Reduces and controls Manufacturing process defects (scrap, nonconforming material, customer complaints), leading or participating in efforts and cross-functional teams focused on identifying the primary root causes and implementing corrective and preventative actions.
• May be responsible for creating risk analyses and FMEAs
• Collects and analyzes process defect date for product/process improvement efforts (e.g., scrap, nonconforming product, customer complaints) by systematically gathering metric data and performing the appropriate analysis method(s) to enhance sustaining product design and new product development.
• Owns and drives Nonconforming Event and Correction and Preventative Action investigations
• Supports continuous improvement activities, NCEPs, CAPA, and Lean initiatives
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Support internal and external regulatory audits.
  
  

Requirements

Education / Certifications

• Bachelor’s Degree in Engineering, Biomedical Engineering, or related science discipline.
• ASQ / CQE certifications
• Six Sigma Certified Green or Black Belt
  
  

Job Requirements

• Minimum of 5 years’ experience in Quality Engineering within a Medical Device Manufacturing environment.
• 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 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