Director of Quality/Regulatory, North America Mobility

Ki Mobility Llc; Village of Plover (WI); On-site; USD 128,000 - 238,000; Full time

Job summary

A leading company in medical equipment manufacturing is seeking a Director of Quality/Regulatory to lead their quality assurance and regulatory compliance strategies. This role involves overseeing compliance with regulatory standards while managing teams to ensure top-tier quality within manufacturing processes. The successful candidate will work onsite in Stevens Point, WI, and must have extensive experience in regulatory affairs within the medical device industry.

Qualifications

• 10+ years of experience in Quality Assurance and Regulatory Affairs.
• 5 years in a senior leadership role.
• Experience in FDA and ISO 13485 compliance.

Responsibilities

• Lead the development and implementation of QA/RA strategies.
• Oversee the Quality Management System for FDA compliance.
• Manage internal and external audit programs.

Skills

Leadership

Project management

Communication

Problem-solving

Education

Bachelor's degree in Engineering Science, Regulatory Affairs, Business, or related field

Tools

Quality tools

Measurement systems

Inspection processes

Job description

Director of Quality/Regulatory, North America Mobility

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Job Summary

The Director of Quality/Regulatory, North America Mobility is responsible for leading, developing, implementing, and maintaining the quality and regulatory strategy and activities across the organization. This role provides leadership in achieving top-tier manufacturing quality and regulatory compliance with FDA, ISO 13485, and international medical device standards. It oversees quality systems supporting manufacturing, supplier management, documentation, training, auditing, and continuous improvement driven by customer feedback.

Job Summary

The Director of Quality/Regulatory, North America Mobility is responsible for leading, developing, implementing, and maintaining the quality and regulatory strategy and activities across the organization. This role provides leadership in achieving top-tier manufacturing quality and regulatory compliance with FDA, ISO 13485, and international medical device standards. It oversees quality systems supporting manufacturing, supplier management, documentation, training, auditing, and continuous improvement driven by customer feedback.

Position will be based onsite at the Stevens Point, WI facility.

For more information on our company and products, please visit www.etac.us.com & www.kimobility.com

Essential Functions

Job Responsibilities

• Lead the development and implementation of QA/RA strategies, goals, and objectives for North America Mobility.
• Develop and implement policies and processes to ensure ongoing compliance of regulatory and quality requirements and standards.
• Oversee the Quality Management System (QMS), ensuring compliance with FDA, ISO 13485, and global medical device regulations.
• Serve as Management Representative (MR) and Person Responsible for Regulatory Compliance (PRRC) ensuring adherence to regulatory obligations including conformity assessment, post-market surveillance, and reporting.
• Hire, manage, and develop QA/RA staff, conduct performance reviews, and align team efforts with company priorities.
• Integrate ISO 14971-based risk management into business processes.
• Develop and maintain quality plans that support quality & regulatory requirements and business objectives.
• Oversee core Quality functions: document control, training, customer feedback, nonconformances, CAPAs, supplier quality, inspections, and final product release.
• Manage internal and external audit programs and implement corrective actions.
• Administer the complaint management system, including evaluation, investigation, and trend analysis.
• Track performance metrics, support strategic planning, and drive continuous improvement.
• Collaborate with product development teams to ensure regulatory compliance of new product releases.
• Stay current on global regulatory requirements (FDA, ISO, EU-MDR 2017/745) and enforcement trends.
• Perform all duties in a manner that follows and promotes a culture of quality, safety, and compliance in accordance with company policies and values.
• Keep the work area clean and orderly.
• Report to work as scheduled, on time, and able to work entire work schedule.
• Perform additional duties as assigned.
  
  

Knowledge, Skills, And Ability

• Exceptional leadership and project management skills.
• Ability to interpret and operationalize complex regulatory requirements.
• Excellent communication skills; written, verbal, and presentation.
• Proficiency in quality tools, measurement systems, and inspection processes.
• Result-oriented, self-motivated, and goal-driven mindset.
• Analytical and problem-solving expertise.
• Proficient in technical writing and interpreting standards and regulations.
• Knowledge of ISO 13485 and global quality system standards.
• Knowledge of continuous improvement and world class quality practices.
• Intermediate level skills using computer applications (Word, Excel, enterprise software).
• Basic math proficiency.
• Ability to work effectively both independently and within a team environment.
• Ability to be highly adaptable and responsive to changing business needs.
• Possess a continuous improvement mindset.
• Ability to work onsite daily with occasional travel requirements.
• Ability to observe and identify details.
• Ability to work extended hours as scheduled, including weekends.
  
  

Physical Demands

• Frequent sitting, wrist manipulation, walking, and standing.
• Frequent bending, pushing, pulling, and twisting.
• Frequent sedentary work with lifting and pushing up to 10 pounds.
• Occasional medium work with lifting and pushing up to 40 pounds.
• Manual dexterity to type and operate office equipment frequently.
• Must be able to complete all physical requirements to perform essential functions.
  
  

Qualifications

Education

• Bachelor's degree in an Engineering Science, Regulatory Affairs, Business, or related field.
  
  

Experience

• Required:
• 10+ years of experience in Quality Assurance and Regulatory Affairs, with at least 5 years in a senior leadership role.
• Experience in the medical device industry (Class I or II)
• Experience in U.S. and international regulations (FDA, ISO 13485, EU-MDR 2017/745, UK MDR 2002, and other global quality regulations and standards).
• Meets the competency requirements defined in MDCG-2019-7 for Person Responsible for Regulatory Compliance (PRRC).
  

Working Environment

• Position is an onsite role at the Stevens Point, WI facility.
• Standard working conditions include a temperature-controlled office and manufacturing environment.
• Position may require up to 10% travel.
  
  

This job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the associate for this position. Duties, activities, and responsibilities may change, or new ones may be assigned at any time with or without notice. Associate must be able to satisfactorily perform the essential functions of the position with or without reasonable accommodations.

Ki Mobility is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, or status as a qualified individual with disability.

Required

Preferred

Job Industries

• Other

Seniority level

• Seniority level

  Director

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Medical Equipment Manufacturing

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