Quality Systems Specialist

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-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 Quality Systems Specialist I role is responsible for providing support for all Quality Management System (QMS) policies, systems, programs, and initiatives.
  
  

JOB RESPONSIBILITIES:

• Participate in all QMS activities including document change control, training and competency, records review and retention, nonconforming material reports (NCMRs), and Corrective and Preventive Actions (CAPAs)
• Supports Quality Team and Management relative to Document Control and Change Management:
• Process documents create/revise to implement Quality System changes
• Utilize document control software to manage controlled procedures (active and archived)
• Ensures that training is appropriately updated and maintained in Grand Avenue Software
• Follows all Quality procedures and policies ensuring that QMS requirements are achieved in an ethical manner.
• Maintains current knowledge of applicable regulations and standards associated with the QMS.
• Assist in internal and external ISO 13485 and FDA 21 CFR Part 820 audits of QMS
• Maintains current understanding and compliance with applicable process procedures and company policies.
• Meets commitments on time, in full, and with accuracy and attention to detail.
  
  

Requirements

• Competent experience with MS-Office (Word, Excel, Power Point, etc.)
• Detail oriented
• Must be able to follow written instructions and procedures
• Adhere to Good Documentation Practice (GDP)
• Must possess good organizational skills
• Must show initiative taking on and completing projects including other assignments as requested
• Must possess good verbal and written communication skills
• Medical device manufacturing experience a plus