JOB OVERVIEW: 

This position is responsible to develop, implement and direct the company’s quality assurance policies, procedures and methods to evaluate and improve the quality of complex products, materials, components and/or operations using standard procedures (e.g. 9001:2015, ISO 13485:2016, QMSR, etc.), and may take all reasonable and prudent steps necessary to maintain compliance with company and product registration requirements, with appropriate notification to, and/or direction from their direct supervisor.

KEY RESPONSIBILITIES: 

• Direct all phases of highly technical quality assurance audit activities.

• Oversee the Quality Management Systems of multiple entities ensuring compliance with global MDSAP requirements as applicable.

• Oversee the preparation, documentation and conduction of Quality Assurance audits of Distribution Centers, joint Ventures, X-Ray Centers, private label manufacturers, non-manufacturing suppliers of Medical Devices and Pharmaceuticals

• Direct and oversee Quality Assurance audits to ensure the effective and timely facilitation of suppliers and internal quality audits and follows-up on CAPAs/Observations.

• Oversee suppliers to assure the quality of their products, materials, components and/or operations.

• Lead in the monitoring of supplier performance efforts and recommend changes to improve the production process.

• Stay current with new or potential business opportunities, and prepare for all QA activities.

• Direct and oversee the research for applicable FDA, ISO and ASTM/ANSI standards to ensure the company’s ongoing compliance with U.S. and International Regulatory Requirements (Medical Devices Directives, Medical Device Regulations, and FDA QS requirements).

• Serve as FDA Official Correspondent for US Facilities and US Agent for foreign HS entities.

• Serve as the Management Representative for the site for interaction with regulatory agencies.

• Serve as Person Responsible for Regulatory Compliance (PRRC) at manufacturing locations for Corporate Brand products, under the European Medical Device Regulation.

• Assist with due diligence and follow-up surveillance audits as required and serve as SME for some manufacturing partners.

• Assess the effectiveness of existing policies, guidelines and procedures and recommend changes.

• Consult and direct process and product transfer projects compliant to the applicable regulations, directives, and standards.Provide ongoing direction and guidance to the team and provide guidance and development opportunities as needed.

• Select, develop, and evaluate TSMs to ensure the efficient operation of the department.

SPECIFIC KNOWLEDGE & SKILLS:

• Knowledge of ISO 9000 certification and maintenance.

• Knowledge of ISO 13485 certification and maintenance.

• Knowledge of the European Medical Device Regulation 2017/745.

• Knowledge of US FDA Quality Management System Regulation

• Knowledge of MDSAP country specific regulatory requirements

GENERAL SKILLS & COMPETENCIES: 

• Outstanding management and leadership skills and ability to attract, retain, motivate, develop, mentor and coach team members for high performance
• Outstanding verbal and written communication skills and ability to resolve disputes effectively
• Outstanding presentation and public speaking skills
• Expert independent decision making, analysis and problem solving skills
• Understand, interpret and act on financial information and external trends that contributes to business profitability
• Plan and manage complex and successful projects; understand available resources, develop timeline, budget and assign areas of responsibility
• Lead teams to achieve company goals and solve complex business issues in creative and effective ways
• Expert planning and organizational skills and techniques
• Communicate effectively with senior management and key stakeholders
• Excellent negotiating skills and ability to effectively manage internal and external relationships
• Ability to influence, build relationships, understand organizational complexities, manage conflict and navigate politics
• Broad professional and managerial skills with a full understanding of industry practices and company policies and procedures
• Lead and develop virtual teams
• Expert in multiple technical and business skills
• Strategic planning skills

MINIMUM WORK EXPERIENCE: 

Typically 12 or more years of increasing responsibility and complexity in terms of any applicable professional experience; 5 or more years of management experience. Experience managing the quality management systems of multiple manufacturing locations is preferred.

PREFERRED EDUCATION: 

Bachelor's Degree or global equivalent in Engineering ,Scienceor related technical discipline.  Master's degree preferred. RAPS and ASQ or other equivalent Certifications preferred.

TRAVEL / PHYSICAL DEMANDS:

Travel typically 25% or more. Office environment. No special physical demands required.