Proactively develop, lead and drive the execution of product quality systems, including the setting of quality goals, managing and improving all aspects of the quality system and product quality with an emphasis on customer use and expectations while balancing the business needs with regulatory compliance worldwide.
- Supervises Quality/Document Systems
- Effectively create and support process enhancement initiatives to maintain an environment of continuous improvement throughout the organization.
- In support of the quality system, provide effective leadership support, training and guidance to all company employees.
- Provide leadership to the quality assurance team, ensuring clear and aligned objectives, support employee development with feedback and coaching, drive employee engagement and encourage collaboration with all stakeholders.
- Identify and implement best practices to improve efficiency and maintain compliance and lead the function in continuous improvement.
- Ensure strategic alignment of quality activities with business objectives to ensure continued compliance and positive audit outcomes.
- Identify and communicate risks; creating strategies and plans to manage risk to the operations.
Qualifications Experience Personal Strengths Mobility
- 10-15 years in quality, regulatory, compliance manufacturing, operations and/or engineering within the IVD and/or medical device industry
- Experience with direct contact with FDA and ISO Notified Bodies.
- Proven experience managing risk management activities.
- Broad business understanding, including global environments.
- Demonstrated knowledge of FDA regulations, ISO 13485:2003, CMDR, Medical Device Directive Regulation (93/42EEC), AATB and other national and international regulations and standards.
-Knowledge of process design and implementation, change control, auditing and document management systems.
- Understanding of immunoassay principles.
- Strong knowledge of statistical analysis.
- Strong leadership, project management skills and ability to influence others in a matrix environment.
- Strong analytical skills, exceptional writing and interpersonal relationship skills.
- Demonstrated organizational, management and communication skills.
- Ability to manage programs within a complex organization and experience in dealing with the top levels of management.
As per local and Company requirements for DiaSorin, Inc.
Others Information as per Local Legal Requirements
Must be 18 years of age, legally authorized to work in the US; and not require sponsorship for employment visa status (e.g, TN, H1B status) now or in the near future.
It is the policy of DiaSorin to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, DiaSorin will provide reasonable accommodations for qualified individuals with disabilities. Our company uses E-verify to confirm the employment eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit www.dhs.gov/E-Verify.
DiaSorin is an EEO/AA employer.
EEO is the Law | http://www1.eeoc.gov/employers/upload/eeoc_self_print_poster.pdf