Henry Schein One LLC is looking for a Director, Quality Assurance - Manufacturing to develop, implement, and direct the company’s quality assurance policies, procedures, and methods. You will be responsible for evaluating and improving the quality of complex products, materials, components, and operations, ensuring compliance with standards like ISO 9001:2015 and ISO 13485:2016.
What You'll Do
- Direct all phases of highly technical quality assurance audit activities.
- Oversee the Quality Management Systems of multiple entities ensuring compliance with global MDSAP requirements.
- Oversee the preparation, documentation, and conduction of Quality Assurance audits of Distribution Centers, Joint Ventures, X-Ray Centers, and suppliers.
- Direct and oversee Quality Assurance audits to ensure effective and timely facilitation of supplier and internal audits, following up on CAPAs/Observations.
- Oversee suppliers to assure the quality of their products, materials, components, and operations.
- Lead in the monitoring of supplier performance and recommend changes to improve production processes.
- Direct research for applicable FDA, ISO, and ASTM/ANSI standards to ensure ongoing compliance with U.S. and International Regulatory Requirements.
- Serve as FDA Official Correspondent for US Facilities and US Agent for foreign HS entities.
- Serve as the Management Representative for interaction with regulatory agencies.
- Serve as Person Responsible for Regulatory Compliance (PRRC) under the European Medical Device Regulation.
- Assist with due diligence and surveillance audits as a Subject Matter Expert.
- Assess the effectiveness of existing policies, guidelines, and procedures and recommend changes.
- Consult and direct process and product transfer projects compliant to applicable regulations.
- Select, develop, and evaluate TSMs to ensure the efficient operation of the department.
What We're Looking For
- Typically 12 or more years of increasing responsibility and complexity in professional experience.
- 5 or more years of management experience.
- Outstanding management, leadership, and team development skills.
- Outstanding verbal, written communication, and dispute resolution skills.
- Outstanding presentation and public speaking skills.
- Expert independent decision making, analysis, and problem solving skills.
- Ability to understand, interpret, and act on financial information and external trends.
- Ability to plan and manage complex and successful projects, including timeline and budget.
- Ability to lead teams to achieve company goals and solve complex business issues creatively.
- Expert planning and organizational skills.
- Ability to communicate effectively with senior management and key stakeholders.
- Excellent negotiating skills and ability to manage internal and external relationships.
- Ability to influence, build relationships, understand organizational complexities, and navigate politics.
- Broad professional and managerial skills with a full understanding of industry practices.
- Ability to lead and develop virtual teams.
- Expert in multiple technical and business skills.
- Strategic planning skills.
Nice to Have
- Experience managing the quality management systems of multiple manufacturing locations.
- Bachelor's Degree or global equivalent in Engineering, Science, or related technical discipline.
- Master's degree.
- RAPS and ASQ or other equivalent Certifications.
Benefits & Compensation
- Medical, Dental and Vision Coverage
- 401K Plan with Company Match
- Generous Time Off
- Paid Parental Leave
- Income Protection
- Work Life Assistance Program
- Flexible Spending Accounts
- Educational Benefits
- Worldwide Scholarship Program
- Volunteer Opportunities
Work Mode
This position is designated as onsite.
Henry Schein is an Equal Employment Opportunity Employer and does not discriminate against applicants or employees on the basis of race, color, religion, creed, national origin, ancestry, disability that can be reasonably accommodated without undue hardship, sex, sexual orientation, gender identity, age, citizenship, marital or veteran status, or any other legally protected status.
