Principal Quality Systems Specialist

Job title            :           Principal Quality Systems Specialist

Client                :           Medical Device Manufacturing company

Duration           :            9  months  with a  possibility for extension

Location           :            Minneapolis, MN, 55432

Shift                  :           On site, 4 days/week

Job Summary

Seeking an experienced Quality Systems Specialist to support global medical device quality systems and regulatory compliance. The role will focus on CAPA, change control, training, audits, risk management, root cause analysis, data analysis, and continuous improvement while partnering with cross-functional teams.

Key Responsibilities

• Support key Quality System processes, including Quality System Change Orders, CAPA, training, issue escalation, audits, and data analysis.
• Manage/support the end-to-end CAPA process, including initiation, root cause analysis, action planning, implementation, verification, and closure.
• Review and approve training plans associated with quality system changes.
• Interpret and apply global medical device regulations, including FDA QMSR, ISO 13485, and European Medical Device Regulation (EU MDR).
• Apply risk management and root cause analysis tools to investigate and resolve quality issues.
• Support internal and external audit preparation, finding resolution, inspections, and communication with auditors/inspectors.
• Perform quality system and process analysis to identify issues and opportunities for improvement.
• Support continuous improvement initiatives to strengthen quality system effectiveness and efficiency.
• Develop, maintain, and improve quality programs, systems, processes, and procedures.
• Support global standardization and best-practice sharing across quality systems.
• Manage assigned quality projects and initiatives from planning through implementation.
• Work with cross-functional teams, internal/external customers, vendors, and stakeholders.
• Provide guidance, coaching, and training to other employees and lower-level specialists.
• Support organizational initiatives and other cross-functional priorities as needed.

HM’s Top Needs

• Strong understanding of FDA QMSR, ISO 13485, and EU MDR
• Strong Quality Systems, CAPA, Change Control, Training, and Management Review experience
• Experience with Risk Management and Root Cause Analysis
• Strong background in audits, inspections, data analysis, issue escalation, and continuous improvement
• Ability to independently manage complex quality projects and processes
• Strong communication, analytical, problem-solving, and stakeholder management skills

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As a leading contract, contract-to-hire and professional placement firm, Three Point Solution understands the importance of aligning our client with the right resource at the right time. We are committed to the highest caliber of service that will benefit our clients, candidates and employees. Unlike large, corporate style recruiting firms, we commit to individualized attention that uniquely positions us to bridge the communication gap between recruiter, employer and candidate. Our goal is to cultivate and maintain true partnerships with our clients and candidates.