Capa Supervisor Ne

Capa Supervisor
Ne
Liguria, Ne

We are looking for a person to insert as CAPA Supervisor to join our Quality Compliance Department based in Bussolengo (VR).

He/She aims cooperate with Quality Assurance team to ensure that the Orthofix Quality System conforms with all reference standards and regulatory requirements (ISO 13485, FDA QSRs, RDC 59/2000 etc. )

and that supplied products are fit for their purpose and meet customer expectations.

He/She co-ordinates the activities required to fulfill this aim.

He/She guarantee to the company that the CAPA opened by the Organization are properly managed.

CAPA process is a critical process with which the Organization assure to minimize the risks associated to a specific non-conformity or potential non-conformity.

It is fundamental to assure that all the CAPA's are properly planned, implemented and verified to avoid the reoccurrence of the identified problem. Directly supervise the CAPA owner and/or an extended team of qualified analysts from multiple functional areas across the site/division in the carrying out of deep and reliable investigations for multiple product lines and systems deemed critical to the success and financial performance of the Division

What we offer

We offer a highly innovative working atmosphere, many learning and development opportunities,

performance-oriented compensation and diverse job fields.

**Responsibilities**:

- Supports the maintenance and continuous improvement of the ISO 13485, MDSAP, etc. . quality management system processes.

- Establishes and drives strategies to achieve site and division quality and compliance goals with regards to the CAPA investigations and the CAPA metrics program.

This includes the establishment of Quality System policies and procedures as needed to ensure compliance.

- Directly supervises an extended team of qualified investigators with members from multiple functional areas across the site/division for carrying out deep analysis and removal of root causes.

- Reviews CAPA investigations performed by qualified staff to ensure that documents are thorough, complete, traceable and timely.

- Manages the resolution confirmation process & works with event owners and division management to measure, ensure and report CAPA quality, timeliness and other compliance parameters.

- Establishes Training material and approaches for members of the CAPA program and ensures training strategies maximize performance and compliance with worldwide regulatory requirements & expectations.

- Leads the CAPA Review Board (CRB) process; executes Quality signatory authority for the review and disposition of nonconforming product in accordance with regulatory requirements.

- Verifies product safety and efficacy have been evaluated and issues related to safety/patient results are elevated for risk evaluation.

- Ensures that the metrics are identified, compiled, and reviewed by a cross-functional team in order to identify adverse trends and the drivers for those trends.

- Works closely with Sr. management and colleagues across the division to ensure the CAPA department provides a responsive, efficient and effective service to customers.

- Authorizes changes to CAPA Management Systems.

- Serves as the primary CAPA system contact during regulatory inspections and Corporate AQR audits.

- Identify and recruit staff and resources to support the CAPA program.

- Collect process metrics and lessons learned, review and evaluate processes, and work products, and recommends improvements as appropriate.

- Support Quality Assurance

- Support QAS to collect, evaluate and analyze Quality records; report periodically to management on corrective and preventive action.

**REQUIREMENTS**:

Education skills

- Preferred degree in Engineering ( especially biomedical) or similar

- 3-4 years in similar positions, or in the management of Quality System in structured company, preferably multinational company and preferably operating in the Medical Device field

- Internal auditor qualification preferably

- Fluency in English ( French and German appreciated)

Soft Skills

- Ability to make decisions and problem solving

- Very good organizational and analytical skills

- Ability to work in team

Other Skills

- Good knowledge of Microsoft Office and familiarity with analysis and reporting tools.

- Travels required according to business needs