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Director of Quality Compliance & Regulatory Affairs

Company: Foxconn
Location: Mount Pleasant
Posted on: September 12, 2020

Job Description:

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 organization.

Job Responsibilities:

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 up.

Manage, administer, and maintain global regulatory compliance licensing.

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 planning.

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 company.

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 performance.

Attract, recruit, motivate, and retain required department personnel.

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 required

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 information.

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 prioritizing

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 training.

Keywords: Foxconn, Mount Pleasant , Director of Quality Compliance & Regulatory Affairs, Other , Mount Pleasant, South Carolina

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