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-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

The Quality Systems Specialist 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

Benefits:

Biomerics offers Medical/Dental/Vision Insurance, Short-Term Disability, Long-Term Disability, Life Insurance, Paid Vacation Days, 9 Paid Holidays, 401k, and an Onsite Fitness Facility.

Note:

Biomerics does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Biomerics' approved agency list. Unsolicited resumes or candidate information submitted to Biomerics by search/recruiting agencies not already on Biomerics' approved agency list shall become the property of Biomerics. If Biomerics subsequently hires the candidate, Biomerics shall not owe any fee to the submitting agency.