Quality Engineer - Pordenone

Baxter International Inc.; Pordenone; In loco; EUR 30.000 - 50.000; Tempo pieno

Descrizione del lavoro

A leading global healthcare company in Pordenone is seeking a Quality Assurance Specialist. The role involves ensuring product quality and compliance, participating in process improvements, and working closely with suppliers. Candidates should have a Bachelor's degree in Quality Management or related fields, alongside demonstrated expertise in quality assurance and strong regulatory knowledge.

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.
• Participate in the improvement of the manufacturing process.
• Work with design engineering for inspection requirements.
• Manage non-conformance troubleshooting operations.
• Assist in development and approval of validation/qualifications.
• Participate in Corrective Action System activities.
• Ensure timely processing of Quality Records per regulations.
• Interface with suppliers to address reported problems.
• Organize supplier audits for compliance with standards.
• Lead new parts qualifications and develop control plans.

Conoscenze

Quality Management

Regulatory Compliance

Problem-Solving

Formazione

Bachelor's degree or equivalent experience

Descrizione del lavoro

Overview

This is where your work makes a difference.

At Baxter, we believe every person—regardless of who they are or where they are from—deserves 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 job—you 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 Functions. In 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 youll 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 company’s 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 supplier’s 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 youll bring

• Bachelor's 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

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.