Quality Assurance Manager (7008)
Quality Assurance Manager (7008)
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Diasorin is a global leader in diagnostic solutions pushing the boundaries of science and technology to create cutting-edge tools that improve healthcare worldwide. With a legacy spanning over 50 years weve earned our reputation for excellence by developing innovative diagnostic assays and instruments that are trusted by healthcare providers around the world.
Our broad offering of diagnostic tests and Licensed Technology solutions made available thanks to ongoing investments in research positions us as the player with the widest range of specialty solutions in the sector and identifies us as the Diagnostics Specialist.
Why Join Diasorin
Impactful Work: When you join Diasorin you become part of a team thats dedicated to improving lives. Your contributions will directly impact patient care making a meaningful difference in the world.
Global Reach & Innovation: Our work transcends borders. Joining Diasorin means collaborating with colleagues from all over the world expanding your horizons and contributing to global healthcare solutions at the forefront of the diagnostic industry.
Diverse and Inclusive Culture: We believe in the strength of diversity and our inclusive culture reflects this commitment. We value your unique perspective and offer a supportive collaborative environment where everyone can thrive.
Join Our Team: If youre passionate about innovation diversity and making a positive impact on healthcare Diasorin is the place for you. Were looking for passionate and talented individuals who are ready to embrace new challenges and drive healthcare solutions forward.
Are you ready to be part of a dynamic team thats shaping the future of diagnostics Join Diasorin and become a catalyst for change in the world of healthcare. Apply today and be a part of our exciting journey toward a healthier more connected world. Together we can make an impact!
Job Scope
The Quality Assurance Manager will lead establish implement and maintain quality assurance systems and activities ensuring compliance with domestic and international quality system standards and regulations for commercial medical devices designed produced and marketed by DiaSorin Molecular/Luminex Licensed Technologies. The Quality Assurance Manager will also provide technical and operational leadership for Quality Assurance activities Quality System development and implementation validations and process development design change corrective and preventive action change control and quality audits and partner with Manufacturing Quality Control and others across functions to deliver the highest quality products. The Quality Assurance Manager is a leader and a mentor for their direct reports.
Key Responsibilities and Duties
- Manages leads and mentors Quality Assurance department and personnel
- Promotes mentors and coaches staff for growth
- Monitors operational performance of the department using Lean principles to improve operational efficiency
- QA lead in Risk Management activities including responses to complaints and recalls
- Quality lead in production team meetings and on-market product technical reviews to ensure quality assurance requirements are met.
- Integral member of production teams. Responsible for ensuring compliance during the design transfer and production process
- Regularly reviews quality system standard operating procedures and work instructions making changes as necessary to ensure compliant and efficient Quality Assurance processes.
- Provides input to the Management Review and Quality Review Board processes and monitors the Quality Management System (QMS) and provides training throughout the organization
- Responds to identified and potential nonconformities complaints deviations and corrective/preventative actions assigned to Quality Assurance
- Participates in Audits internal and external as SME or escort
- Key member of select Review Boards as per Quality processes (e.g. MRB CRT ORB SRB)
- Responsible for all aspects of QMS compliance
Education Experience and Qualifications
- Bachelors Degree Preferably in a life science/engineering discipline or minimum 5 years work experience in a regulated/medical device industry required
- 5 Years Demonstrated knowledge of current industry quality practices under ISO 13485 ISO 14971
- 1 Years Management experience in a complex quality assurance/quality systems field
- 1 Years Ability to provide leadership to others in the organization through influence innovative practices and coaching skills to foster a corporate culture of responsiveness compliance awareness self-regulation quality system ownership challenge of status quo and continuous improvement in order to achieve the highest level of compliance.
- 1 Years Possesses a strong scientific and technical background sufficient to establish creditability with senior management as well as the manufacturing and product development teams.
- 1 Years Excellent problem solving methodology using industry accepted concepts and tools to solve complex problems in creative and effective ways as they apply to compliance issues
- 1 Years Hands-on ability to sort through technical complexities and work in a flexible changing environment.
- Excellent interpersonal verbal and written communication skills
- Thorough knowledge of standards and regulations (cGMP ISO 13485)
- Highly organized with proven time management and prioritization skills
- High degree of problem solving attention to detail and analytical skills.
- Certification in a quality discipline preferred such as CQM CQA
- Ability to work independently and with minimal supervision
- Experience working independently in a fast-paced environment with rapidly changing priorities
- Knowledge of Lean principles (e.g. 5S Kaizen six sigma etc.)
- Local and international travel may be required approximately 10% of the time
Diasorin is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity national origin or protected veteran status and will not be discriminated against on the basis of disability.
In compliance with federal law all persons hired will be required to verify identity and eligibility to work in the United States and Canada and to complete the required employment eligibility verification document form upon hire.
Diasorin is committed to providing reasonable accommodations for qualified individuals with disabilities. If you are a US or Canada candidate and require assistance or accommodation during the application process please contact the North America Talent Acquisition Team at or 1- to request an accommodation.
The above job description is intended to describe the general content identify the essential functions and set forth the requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties responsibilities or requirements.
Diasorin reserves the right to modify or amend this job posting as needed to comply with local laws and regulations.
Please note that offers of employment at Diasorin may be contingent upon successful completion of a pre-employment background check and drug screen subject to applicable laws and regulations.
This position is not eligible for partnership with a third-party search firm vendor without expressed written consent from the Diasorin Human Resources Department.
Required Experience:
Manager
Employment Type
Full-Time
