Quality Systems Specialist

Biomerics • Brooklyn Park, MN

13d • $21 - $24

About The Position

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

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

Nice To Haves

• Medical device manufacturing experience a plus

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.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: No Education Listed
• Number of Employees: 501-1,000 employees