Prin Quality Systems Spec - Exempt

HM's Top Needs:

1. Strong understanding of global regulatory requirements for medical devices, including FDA Quality Management System Regulation (QMSR), ISO 13485, and European Medical Device Regulation.

2.Strong understanding of quality systems, including CAPA, change control, training, and management review

3.Familiarity with risk management and root cause analysis tools

• 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: Bachelors

Years Experience Required: 7 years

Will the contractor be working 40 hours a week? If not, weekly estimate? 40 hours/week

Work Location: Rice Creek East

Do they need to be local to any MDT office and if so where? Rice Creek East, Fridley MN

Does this person need to be on site? If so, full time or part time? On-site 4 days/week

Responsibilities may include the following and other duties may be assigned. 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. SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University). DIFFERENTIATING FACTORS Autonomy: Recognized expert, managing large projects or processes . Exercises considerable latitude in determining deliverables of assignments, with limited oversight from manager . Coaches, reviews and delegates work to lower level specialists. Organizational Impact: Contributes to defining the direction for new products, processes, standards, or operational plans based on business strategy with a significant impact on work group results . May manage large projects or processes that span outside of immediate job area. Innovation and Complexity: Problems and issues faced are difficult, moderately complex and undefined, and require detailed information gathering, analysis and investigation . Develops solutions to moderately complex problems, and/or makes moderate to significant improvements of processes, systems or products independently to enhance performance of job area. Implements solutions to problems. Communication and Influence: Represents organization as a primary contact for specific projects and initiatives; communicates with internal and external customers and vendors at various levels . May negotiate with others to reach understanding or agreement, and influence decisionmaking. Leadership and Talent Management: Typically provides guidance, coaching and training to other employees within job area. Typically manages major / moderately complex projects, involving delegation of work and review of work products, at times acting as a team leader. Required Knowledge and Experience: Requires mastery of a specialty area and full knowledge of industry practices, typically obtained through advanced education combined with experience. May have broad knowledge of project management. Requires a University Degree and minimum 7 years of relevant experience, or advanced degree with a minimum of 5 years of relevant experience.