**Careers that Change Lives**
In HbioFluids site Italy, we employ approximately 80 people (HbioFluids - Tovo di Sant'Agata - SO) who are all directly engaged in the manufacture of pharmaceutical and medical device fluids and concentrates used in the dialysis procedure.
We are searching for **You **.
As **Quality System Specialist **the most important responsibility that you will have includes managing and maintaining the Quality System for the company dealing with internal policy and local regulations and laws.
The role will be directly involved in supporting the execution of manufacturing and continuous improvement strategies and objectives for the Hbio production site, guaranteeing the Quality Assurance tasks and objectives.
**A Day in the Life**:
- Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.
- Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
- Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.
- Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.
- Prepares reports and/or necessary documentation (ex Corrective and Preventative Actions) and provides to applicable stakeholders, both internal and external.
- Co-ordinates legal requests in support of government investigations or litigations.
- Ensures the quality assurance programs and policies are maintained and modified regularly.
- Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally.
**Must Haves**:
- Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R.
- 214.2(h)( 4)(iii)(A), Master Degree in Chemistry, Pharmacy, Biology, Biological Engineer
- Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience, of relevant experience, of 1-2 years.
**Nice to Haves**:
- Established and productive individual contributor.
Works independently with general supervision on larger, moderately complex projects / assignments.
- Sets objectives for own job area to meet the objectives of projects and assignments.
Contributes to the completion of project milestones.
- Communicates efficiently and frequently with internal and external contacts and partner.
Contacts others to share information, status, needs and issues in order to inform, gain input, and support decision-making.
**We Offer**
We offer a competitive salary and benefits package to all our employees:
- Flexible working environment
- Annual Incentive Plan % depending on company results
- Pension scheme and group discount on healthcare insurances
- Training possibilities via Cornerstone/Harvard Manage Monitor/GetAbstract
- Employee Assistance Program and Recognize!
(our global recognition program)
This position is based in Italy, Tovo di Sant'Agata - SO.
**About Medtronic**Bold thinking.
Bolder actions.
We are Medtronic.
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 90,000+ passionate people.
Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day.
Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world.
In everything we do, we are **engineering the extraordinary **.
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