Quality Engineer Pordenone

Baxter; Pordenone; In loco; EUR 35.000 - 50.000; Tempo pieno

Descrizione del lavoro

A healthcare technology company in Pordenone, Italy, seeks a Quality Assurance Specialist to drive product quality improvements and ensure compliance. The role involves managing non-conformance, supporting validations, and conducting supplier audits. Candidates should possess a bachelor's degree in quality management or life sciences, with expertise in regulatory requirements specific to the healthcare industry.

Competenze

• Demonstrated expertise in quality assurance or a related industry.
• Strong knowledge of regulatory requirements and quality standards in the healthcare industry.

Mansioni

• Drive product quality improvements and ensure product compliance to requirements and regulation.
• Participate in the improvement of the manufacturing process for existing products.
• Manage non-conformance trouble‑shooting operations to confirm and resolve part defects.
• Assist in development review and approval of process and equipment validation/qualifications.
• Ensure accurate and timely processing of all Quality Records.
• Interface with suppliers, engineering, and quality organizations to address reported problems.
• Organize and conduct supplier audits to ensure compliance with standards.
• Lead new parts qualifications together with R&D and sourcing based on the SNAP process.

Conoscenze

APQP

Quality Assurance

Six Sigma

ISO 9001

PPAP

Minitab

Root cause Analysis

ISO 13485

Quality Systems

Quality Management

AS9100

Manufacturing

Formazione

Bachelor's degree in Quality Management Engineering or Life Sciences

Descrizione del lavoro

This is where your work makes a difference.

At Baxter we believe every personregardless of who they are or where they are fromdeserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today tomorrow and beyond.

Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together our community is driven by a culture of courage trust and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations and we hold each other accountable for delivering exceptional results.

Here you will find more than just a jobyou will find purpose and pride.

Become a Quality Assurance Specialist within our Pordenone Italy Team!

This quality assurance role is responsible for supporting the quality related matters associated with support for medical video management system at Pordenone a Baxter company. This position will also be responsible overseeing and / or assisting with a variety of Quality Engineering addition this position will work to provide the necessary data to make effective quality and business decisions and implement sound data-driven quality and business solutions that emphasize quality system compliance.

What You Will Be Doing

• Drive product quality improvements and ensure product compliance to requirements and regulation. Work closely with Operations to identify and resolve production and quality system deficiencies.
• Participate in the improvement of the manufacturing process for existing products. Review and approve job instructions inspection documents bills of material and drawings.
• Work with design engineering to determine receiving inspection requirements of purchased components finish products and enabling a smooth design transfer. Provide technical quality engineering support to receiving inspection.
• Manage non-conformance trouble‑shooting operations to confirm and resolve part defects and associated documentation.
• Assist in development review and approval of process and equipment validation / qualifications (IQ OQ & PQ).
• Participate in Corrective Action System activities including evaluation of failure investigation and corrective action plans.
• Ensure accurate and timely processing of all Quality Records along with the companys regulatory compliance profile per EU MDR and 21CFR820 regulations.
• Partner with Sustaining Engineering and Research & Development for product and process change control documentation and specifications.
• Use quality tools and practices to establish approval criteria to ensure the identification of quality failure concerns for both internal and external manufactured parts and assemblies (e.g. FMEA (Failure Modes Effects Analysis). Ensure appropriate controls (key metrics) are implemented and satisfactorily completed for your responsibility.
• Interface with suppliers engineering and quality organizations to efficiently address reported problems impacting functionality quality and regulatory requirements.
• Driving constantly supplier improvement initiative. Start and supervise corrective actions in cooperation with various departments of Videomed and the supplier.
• Carrying out root cause and error analyses in the event of non-conformity of products caused by suppliers.
• Keep suppliers in a state of control. E.g. through monthly verification of KPIs.
• Organize and conduct supplier audits to ensure that products and services meet EN ISO13485 / ISO9001 and relevant regulatory standards.
• Execute and manage Supplier Quality projects often in collaboration Sourcing Department.
• Participation in the negotiation of quality assurance agreements with suppliers.
• Leading new parts qualifications together with RnD and sourcing based on the SNAP process including developing control plans that define supplier processes and identify risk areas.
• Review and agree on design development changes and supplier change requests to determine part requalification needs.

What You Will Bring

• Bachelors degree or equivalent experience in a field like Quality Management Engineering or Life Sciences.
• Demonstrated expertise in quality assurance or a related industry.
• Strong knowledge of regulatory requirements and quality standards in the healthcare industry.

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race color religion gender national origin age sexual orientation gender identity or expression protected veteran status disability / handicap status or any other legally protected characteristic.

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If because of a medical condition or disability you need a reasonable accommodation for any part of the application or interview process please click on the link here and let us know the nature of your request along with your contact information.

Recruitment Fraud Notice

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Key Skills

APQP, Quality Assurance, Six Sigma, ISO 9001, PPAP, Minitab, Root cause Analysis, ISO 13485, Quality Systems, Quality Management, AS9100, Manufacturing

Employment Type: Full‑Time

Experience: Years

Vacancy: 1