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Quality Assurance and Regulatory Affairs Manager
hace 3 semanas
The Quality Assurance and Regulatory Affairs Manager will drive the strategic and operational performance of the Quality department. This position ensures the successful delivery of business strategy and operational goals to exceed customer expectations for product quality, customer service, engineering quality, cost and delivery, while facilitating continuous improvement and achieving commercial success. The Manager will lead and manage the quality team and ensure the efficient and effective day to day running of the department.
The Quality Manager must be a change agent and possess hands-on management skills.
**Job Functions include but are not limited to**:
- Assist in developing and/or executing strategic plans to meet departmental and organizational goals while complying with regulatory and customer requirements.
- Lead, develop and coordinate the requirements necessary to meet ISO, FDA-GMP and customer audit compliance in the most cost-effective manner.
- Manage the routine activities of the Quality Laboratory including: a) selection, development, evaluation, motivation and retention of qualified personnel; b) operation of the department within appropriate budgetary constraints; c) consistent administration of Company policies and procedures; d) maintenance of an orderly work environment.
- Administration and coordination of the Customer Complaint System including assuring timely communication with the customer, sales, manufacturing, engineering and other personnel.
- Continually partner with Product Development Engineers and customers to develop specifications to ensure that customer requirements and company specifications match. Resolve contradictions with customer’s specifications and procedures.
- Provide leadership and guidance to assure corrective actions are resolved, adequate root cause analysis is completed and short/or long-term corrective actions are implemented.
- Ensure strong communication with complaint responses or other Q.A. concerns with other departments; facilitate exchange of information in order to implement change and improvements regarding quality.
- Identify and pro-actively lead continuous improvement actions to prevent non-conformances working closely with internal and external customers.
- Provide progress reports/Quality Key Performance Indicators (KPIs) to Senior Management.
- Develop, implement, and maintain Quality Systems.
- Drive key performance indicators to all levels within the organization related to Quality Assurance and participate in making recommendations for necessary changes to enhance the business objectives.
- Prepare and conduct formal management review meetings and follow up.
- Responsible for publishing and approving documents. Maintaining and continuously improving quality system processes as required by international, regional and national regulatory authorities and standards, ISO 9001 and FDA QSR.
- Functioning as the management representative during audits, internal and external.
**Experience**:
- 10 to 15 years experience related to Quality/Regulatory System Development and Management.
- 5+ years of experience working in an FDA regulated environment.**[TF1]**
- 5 to 10 years experience managing people
**Other skills and abilities**:
- Understanding of FDA’s Quality System Requirements, 21CSR820, ISO 9001 and ISO 13485.
- Knowledge of other regulatory processes: 510K, DMS, DMR, DHR, process validation and statistical quality tools.
- Understanding and knowledge of working in a clean room manufacturing environment.
- Excellent oral and written communication skills.
- Excellent leadership skills.
- Knowledge of lean manufacturing, Six Sigma and team problem solving.
[TF1]Select the MINIMUM level of experience that is needed to be hired for this position.
Tipo de puesto: Tiempo completo, Por tiempo indeterminado
Salario: $120,000.00 - $140,000.00 al mes
Horario:
- Diurno
- Lunes a viernes
Prestaciones:
- Aumentos salariales
- Estacionamiento de la empresa
- Opción a contrato indefinido
- Seguro de gastos médicos
- Seguro de gastos médicos mayores
- Seguro dental
- Teléfono de la empresa
- Vacaciones adicionales o permisos con goce de sueldo
- Vales de despensa
Tipos de compensaciones:
- Bono anual
- Bono de productividad
- Bono de puntualidad
Experiência:
- REGULATORIO DE CALIDAD: 10 años (Obligatorio)
- EMPRESA MEDICA: 5 años (Obligatorio)
- Amplio conocimiento en ISO 13485: 5 años (Obligatorio)
- Amplio conocimiento en IATF: 5 años (Obligatorio)
- Amplio conocimiento de regulaciones FDA: 10 años (Obligatorio)
Idioma:
- Ingles CONVERSACIONAL 90% (Obligatorio)
Lugar de trabajo: Empleo presencial
