Sr Quality Systems Spec ExemptThree Point Solutions • Brooklyn Center, Minnesota, USA
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Sr Quality Systems Spec Exempt
Three Point Solutions • Brooklyn Center, Minnesota, USA
[job_card.30_days_ago]
[job_preview.job_type]
- [job_card.full_time]
[job_card.job_description]Bachelors Degree with a minimum of 5 years of relevant experience or advanced degree with at least 3 years of experience. Experience within a medical device pharmaceutical or regulated environment . Experience managing large-scale cross-functional projects. Strong knowledge of Quality System Management principles. Proficient in Microsoft Office applications. Lean / Six Sigma certification . Project management and risk mitigation experience. Prior involvement in acquisitions or mergers . Deep understanding of FDA 21 CFR Part 820 Part 11 and ISO 13485 standards. Familiarity with PLM systems (Agile Windchill). Strong analytical process improvement and decision-making skills. Proven ability to mentor junior professionals and manage complex quality initiatives. Advanced professional expertise combining both breadth and depth of QMS understanding. Works independently under limited supervision managing end-to-end project execution. Provides guidance coaching and training to other quality professionals. Communicates with senior leadership and external stakeholders to influence decisions and ensure compliance excellence.
Job Title : Quality Systems Specialist
Client : Medical Device Manufacturing Company
Duration : 12 Months (Possible Extension)
Location : Brooklyn Center MN 55430
Shift : 1st Shift 100% On-site
Role Overview
The Sr. Quality Systems Specialist will be responsible for overseeing and integrating Quality Management System (QMS) processes across multiple locations. This role ensures compliance with FDA and ISO standards while driving continuous improvement in quality systems and cross-functional collaboration.
Key Responsibilities
- Support integration of QMS processes across sites and departments.
- Evaluate and align interactions between QMS elements across Development Operations Quality and Supply Chain.
- Review and update QMS documentation including procedures manuals plans and agreements.
- Coordinate training requirements and ensure compliance readiness.
- Provide oversight for quality programs and ensure adherence to internal and regulatory standards.
- Lead or support audit and inspection readiness corrective actions and compliance reporting.
- Work closely with functional leaders to identify process improvements and standardize best practices.
- Act as a subject matter expert on regulatory compliance (FDA 21 CFR 820 ISO 13485).
Required Qualifications
Preferred / Nice to Have
Knowledge & Experience Level
#ZR
Key Skills
Computer Science,Active Directory,Computer information Technology,PowerShell,OS,Windows,Database,SCCM,Linux,SAN,Troubleshoot,Backup,Setup,Technical Support,UNIX
Employment Type : Full Time
Experience : years
Vacancy : 1
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