Director of Quality Compliance & Regulatory Affairs
Foxconn Industrial Internet (Fii) provides innovative design and
advanced manufacturing capabilities through a variety of
customer-driven solutions. Dedicated to the expansion of smart
Industry 4.0 methodology, Fii is creating a new customer design
center to rapidly develop and scale new products in Wisconsin's new
manufacturing center. Join an expansive network of professionals
who embody an entrepreneurial spirit that works together within a
company culture of shared mission.
The Director of Quality Compliance & Regulatory Affairs is
responsible for managing, leading and developing a team of
qualified professionals to manage all Quality Assurance aspects of
the Quality Management System (QMS) to ensure that process and
procedures are compliant within a contract manufacturing
Manage, administer, and maintain the company’s compliance
systems (i.e., NCMR, CAPA/SCAR, Management Review, Risk Management,
External Standard Change Management, Device History Record Review,
Fields Actions, Customer Complaints, Regulatory Product,
Distribution Authorization, Internal and External Audits, and as
required, Product Label Reconciliation).
Assures processes are executed in compliance with company
policies and procedures, as well as FDA Quality System Regulations
and International Regulations, including 21CFR Part 820,
ISO13485:2016, and E-MDR 2017 / 745 standards.
Ensures the organization has an “Inspection Ready” program with
personnel preparation for hosting inspections and inspection follow
Manage, administer, and maintain global regulatory compliance
Keep Executive Stakeholders apprised of expected changes to the
regulatory landscape affecting existing and future company products
and provide strategic and tactile direction to drive
cross-discipline consistency in regulatory approach and
Interface with internal auditors and external regulatory
agencies, establish and maintain required regulatory requirements,
and support required audits.
Collaborate with other departments and teams to develop and
implement the operational infrastructure of systems, processes, and
personnel designed to accommodate the growth objectives of the
Prepare department budgets, financial department planning of
demand forecasts, execute operations to the budget, and advise
Executive Stakeholders of risk.
Provide employee mentoring for career development.
Plan, assign, and direct department work, assess operational
process performance, assess, reward, and resolve employee
Attract, recruit, motivate, and retain required department
Provide quality leadership, continuous improvement, and
direction to the department.
Other duties as assigned.
Education Requirements and Ideal Experience:
Education: Bachelor’s degree required
10+ years of relevant Quality Management Experience is
10+ years of people management experience working within a
Quality Management capacity.
ASQ or equivalent Quality Auditor (CQA) certification desirable,
but not required
Understanding of, and ability to apply, global medical device
QMS regulations and guidance using a risk-based approach (e.g.,
ISO13485, US FDA, MDSAP, EU MDR).
Ability to function in a controlled environment regulated by FDA
GMP’s and handles restricted, confidential, private, or personal
Critical thinking and problem-solving abilities.
Excellent decision making and leadership capabilities.
Resourceful team player with can-do attitude, global mindset and
intercultural openness, intercultural awareness, and ability to
cooperate and navigate in virtual settings.
Skills and Knowledge
Proficient in computerized quality management systems (e.g.,
Agile, Master Controls, AssurX, ETQ).
Highly collaborative, team-oriented
Highly adaptable/flexible mindset
Strong organizational skills in planning, organizing and
Ability to communicate and work well with teams with a variety
of diverse people and a global workforce
Proficient in Microsoft Office (Excel, PowerPoint, Word)
Mandarin Chinese speaker a plus, however not essential
Traditional Chinese writer a plus, however not essential
Foxconn Full-Time, Permanent Employees:
Accrue ten (10) personal days off and ten (10) vacation days off
during calendar year.
401K savings plan eligibility upon completion of three (3)
months of full-time employment.
Ten (10) paid Holidays.
Group Health Insurance Plans the first day of the month
following the date of hire.
Foxconn provides equal employment opportunities (EEO) to all
employees and applicants for employment without regard to race,
color, religion, sex, national origin, age, disability or genetics.
In addition to federal law requirements, Foxconn complies with
applicable state and local laws governing nondiscrimination in
employment in every location in which the company has facilities.
This policy applies to all terms and conditions of employment,
including recruiting, hiring, placement, promotion, termination,
layoff, recall, and transfer, leaves of absence, compensation and