Director of Quality Assurance and Compliance

• 15 years of experience in Quality/Regulatory in FDA regulated company and experience with ISO 13485 ISO 14971 Risk Management FDAs QSR for medical devices relevant applicable ISO Standards International Regulations
• Minimum of 7 years of leadership experience is required
• Bachelors degree in Engineering Quality Assurance Manufacturing or Business Administration
• Change leadership coaching managing multiple priorities problem solving Project Management

• Masters Degree in Engineering Quality Assurance Manufacturing or Business Administration

• CQE CMQ/OE CQA regulatory study degree/certification and Quality systems auditor preferred
• Knowledge of QA document processes and systems failure mode and effects analysis statistical tools including statistical process control and product vigilance and complaint handling
• Strong knowledge of domestic and international regulatory requirements (i.e. FDA GxPs and ISO/EN standards).
• Excellent communications and interpersonal relationship skills including negotiating and relationship management with the ability to drive achievement of objectives. Must have proven ability to lead a diverse team of Quality Assurance and Complaint Management personnel. Excellent communication skills and the ability to work well with cross-functional teams at all levels are essential.
• Must be able to demonstrate strong organizational and managerial skills.
• Capability of working independently taking ownership for the management of processes projects and timelines.
• Ability to effectively influence affiliates regulatory agencies and internal and external partners to ensure that business needs are met.

• Requires normal visual acuity and hearing.
• Typically employees sit comfortably to do their work interspersed by brief periods of standing walking bending carrying papers and books and extensive periods requiring the use of computer terminals to accomplish work objectives.
• Required to sit and use their hands and fingers to handle or feel and manipulate keys on a keyboard.
• Additional skills may be required to perform additional task(s) specific to work location department or line of business.

• Predominantly operates in an office environment. Some work (less than 5%) requires moving and lifting heavy networking equipment.

• Member of site Senior management staff providing representation for Quality functions and personnel.
• Direct Quality Assurance & Compliance Quality Systems and Complaint management functions.
• Identify and lead continuous development and implementation of global quality and regulatory compliance strategy.
• Lead development and maintenance of robust Quality Management System (QMS) that adheres to Good Manufacturing Practices (GMP) and regulatory requirements.
• Select and maintain best practice and compliant quality systems and processes in support of global quality policy.
• Monitor technological trends such as emerging standards and new technology opportunities.
• Manage planning and implementation of the Quality Management System (QMS) including creation and implementation of corporate processes process maps procedures and tools in compliance with all applicable industry local national and international regulatory requirements and standards.
• Act as Quality Management Representative and liaison with regulatory bodies regarding compliance and complaint reporting. Serve as the primary contact for regulatory agency and 3rd party interactions for Company products including site visits audits and inspections.
• Develop lead and collaborate for FDA-483 or Warning Letter remediation activities per plan.
• Work closely with Marketing Engineering Manufacturing Service and other internal and external partners to ensure effective efficient and well-established Quality & Compliance processes.
• Provides customer focused interactions.
• Provide directions to team responsible for quality process improvements corrective actions complaint analysis and risk management.
• Strong understanding of regulatory requirements of US and International markets.
• Gain cross-functional alignment to establish new processes and implement effective change management.
• Continuously seek innovative ways to improve business productivity through introduction of new quality system technologies methods and controls.
• Establish product quality and process metrics that effectively measure and improve performance.
• Promote best practices to design develop and manufacture products that will meet and exceed customers expectations.
• Develop and execute a strategic vision for the Quality Management System aligned with the companys long-term objectives.
• Report to Executive Management on status suitability and effectiveness of Quality System including quality policies and objectives through Management Review process.
• Develop and effectively manage operating staffing and projects budgets.
• Manage full-time or temporary resources based on work level demands and budgetary constraints.
• Plan and execute staffing and compensation decisions.
• Provide leadership to coach and mentor and retain a knowledgeable and competent staff that is effectively organized to deliver high quality service to users meet time commitments.
• Foster an environment which motivates the achievement of desired business results.
• Attend and participate in departmental meetings.
• Attend seminars and training sessions necessary to maintain appropriate level of professional competence.
• Ensure all department compliance guidelines are met.
• Attend all meetings in-services training or continuing education as delegated by the supervisor.
• Performs all duties necessary for the department as per department policies and procedures.
• Performs other duties and responsibilities as delegated by the supervisor within the scope of practice and the responsibilities in the department. Minimal travel required.

Required Experience:

Director