Principal Quality Systems Specialist

Principal Quality Systems Specialist (Through April 2027 // Minneapolis, MN):

Candidate must be on-site 4 days/week

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Required Skills:

• Strong understanding of global regulatory requirements for medical devices, including FDA Quality Management System Regulation (QMSR), ISO 13485, and European Medical Device Regulation.
• Strong understanding of quality systems, including CAPA, change control, training, and management review
• Familiarity with risk management and root cause analysis tools

Primary Responsibilities:

• Support key Quality System processes, including Quality System Change Orders, training, CAPAs, issue escalation, internal and external audits, and data analysis.
• Support the end-to-end CAPA process, including initiation, root cause analysis, action planning, implementation tracking, verification, and closure, to ensure timely and effective resolution of quality issues in compliance with internal procedures and regulatory requirements.
• Review and approve training plans associated with change orders to ensure training requirements are appropriately defined, documented, and completed.
• Support continuous improvement activities by helping to implement improvements to strengthen quality system effectiveness and efficiency.
• Support key organizational initiatives and cross-functional priorities as needed.

Education Required:

Bachelor’s Degree in Engineering or similar scientific discipline

Years’ Experience

Required:

7 years of experience with CAPAs and Quality Systems Change Orders

Duties:

• Provides oversight for the development and maintenance of quality programs, systems, processes, and procedures that ensure compliance with policies and that the performance and quality of services conform to established standards and agency guidelines.
• Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and agency guidelines to assure compliance.
• Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet guidelines.
• Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.
• Coordinates legal requests in support of government investigations or litigations.
• Ensures the quality assurance programs and policies are maintained and modified regularly.
• Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally.