Quality Control Engineer, Associate

Description

 Company Overview

Biomerics is a world-class manufacturer and innovative polymer solutions provider for the medical device and biotech indus-tries. As a vertically integrated company, we specialize in designing, developing, and producing medical devices for diagnostic and interventional procedures. We are focused on next-genera-tion 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 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 the 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-fo-cused corporate culture prioritizes building strategic, mutually beneficial partnerships with customers and our team members.

Job Description

The Associate Quality Control Engineer will support the Quality team by assisting with inspection and quality control activities. Learn to apply quality standards and procedures, follow guidelines to perform inspections, and help ensure products meet customer and internal requirements. Work closely with supervisors and production teams while gaining experience in quality methods and tools.

• Assist in performing inspections of parts and assemblies according to set procedures
• Help train and support production staff on basic inspection equipment use
• Collect and record inspection and quality data under supervision
• Follow established guidelines to identify and report product issues
• Work with Quality and Production teams to support daily operations and quality improvements
• Assist with qualification activities for parts and assemblies
• Support basic metrology tasks, including using measurement tools and fixtures
• Maintain consistent attendance and follow safety protocols
• Complete other duties as assigned by Quality leadership

Requirements

• Engineering bachelor’s degree with 1-2 years quality experience, or
• Associate degree with 3+ years quality experience, or
• Minimum 5 years quality experience

Should have specific training and working knowledge in the following areas:

• ISO 9001:2015 and ISO 13485:2016
• Medical Validation - IQ, OP, PQ Experience – Protocols 
• PPAP – Production Part Approval Process 
• APQP – Advanced Product Quality Planning
• Core Documents: Control Plans, PFMEA, Flow Diagrams, Work Instructions, & Inspection Instructions
• GR&R – Gage Repeatability & Reproducibility 
• MSA – Measurement System Analysis
• CAPA – Corrective Action / Preventive Action 
• Advanced Problem-Solving Techniques - 8D, 3L5Y, Fishbone
• Metrology Experience - OGP / QVI / Optical Comparator / CMM / Keyence Vision System & Handheld Equipment
• Print Reading / Advanced GD&T Experience
• Strong Microsoft Office Knowledge:  Excel, Word, PowerPoint
• SPC - Statistical Process Control and evaluation
• Data Analytical Skills – Minitab Software