Director of Quality Assurance

This position is responsible for developing, implementing, and directing the company’s quality assurance policies, procedures, and methods to evaluate and improve the quality of complex products, materials, components, and/or operations. Key responsibilities include: Directing all phases of highly technical quality assurance audit activities. Overseeing the Quality Management Systems of multiple entities to ensure compliance with global MDSAP requirements. Overseeing the preparation, documentation, and conduction of Quality Assurance audits. Directing and overseeing Quality Assurance audits to ensure the effective and timely facilitation of suppliers and internal quality audits. Overseeing suppliers to assure the quality of their products, materials, components, and/or operations. Leading in the monitoring of supplier performance efforts and recommending changes to improve the production process. Staying current with new or potential business opportunities and preparing for all QA activities. Directing and overseeing the research for applicable FDA, ISO, and ASTM/ANSI standards. Serving as FDA Official Correspondent for US Facilities and US Agent for foreign HS entities. Serving as the Management Representative for the site for interaction with regulatory agencies. Serving as Person Responsible for Regulatory Compliance (PRRC) at manufacturing locations. Assisting with due diligence and follow-up surveillance audits as required. Assessing the effectiveness of existing policies, guidelines, and procedures and recommending changes. Consulting and directing process and product transfer projects compliant to applicable regulations, directives, and standards. Providing ongoing direction and guidance to the team and providing guidance and development opportunities as needed. Selecting, developing, and evaluating team members to ensure the efficient operation of the department. Specific knowledge and skills required include: 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 and competencies required include: Attracting, retaining, motivating, coaching, and developing team members for high performance. Excellent writing and communication skills. Excellent analysis and problem-solving skills. Understanding, interpreting, and acting on financial information that contributes to business profitability. Ability to plan and manage complex projects, manage risks, costs, time, and project teams. Excellent planning and organizational skills and techniques. Communicating effectively with senior management and key stakeholders. Using skills to lead teams to achieve company goals in effective ways. Ability to influence, build relationships, navigate politics, and manage conflicts. Broad and wide-range of professional and managerial skills with a full understanding of industry practices and company policies and procedures. Ability to lead and develop virtual teams. Strategic planning skills. Budget development and monitoring skills. Typically, 10 or more years of increasing responsibility and complexity in terms of applicable professional experience, and 5 or more years of management experience are required. A Bachelor's Degree or global equivalent in Engineering, Science, or a related technical discipline is preferred, with a Master's degree and RAPS and ASQ or other equivalent certifications also preferred. Travel requirements are typically 25% or more. The company offers a range of benefits, including medical, dental, and vision coverage, 401K plan with company match, PTO, paid parental leave, income protection, work-life assistance program, flexible spending accounts, educational benefits, worldwide scholarship program, and volunteer opportunities. The posted salary range for this position is $141,755 to $194,913, which is the expected starting base salary range for an employee who is new to the role to fully proficient in the role. Many factors go into determining employee pay within the posted range, including education, prior experience, training, current skills, certifications, location/labor market, internal equity, etc.

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