Capa Supervisor (Remote)

Quality Compliance Engineer

We offer an interesting opportunity to join our Quality & Regulatory team, based in Bussolengo (VR) as a Quality Compliance Engineer, reporting to the Senior Quality Compliance Manager, on a temporary contract of one year.

In this position you will cooperate with Quality Assurance team to ensure that the Orthofix Quality System conforms with all reference standards and regulatory requirements (ISO 13485, MDSAP, FDA QSRs, RDC 59/2000 etc.) and that supplied products are fit for their purpose and meet customer expectations. You will guarantee to the company that the CAPA opened by the Organization are properly managed.

Responsibilities include supporting the company in the management of the QMS documentation and its updates, collaborate in the internal audit process to confirm the compliance of the system and internal process to requirements, address possible deviations identified and support the elaboration of post market reports providing compliance data to the team.

This position must deal with other company departments and international colleagues. Especially Consultants, Subsidiaries, Competent Authorities, Distributors, External laboratories, suppliers and Notify Body.

What will your contribution be?

• 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.
• 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.
• Support monitoring of quality system health state collaborating in internal and external audits.
• Support QAS to collect, evaluate and analyze Quality records; report periodically to management on corrective and preventive action.

What are we looking for?

• Preferred technical degree in Engineering (especially biomedical) or similar
• 1-2 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 welcome
• Excellent English written and spoken required
• Good knowledge of Microsoft office and with analysis and reporting tools

What soft skills will you improve?

• Critical Thinking
• Ability to make decisions and problem solving
• Very good organizational and analytical skills
• Ability to work in team

What will you find?

• Friendly, warm, and innovative atmosphere
• Healthy, inspiring, and international and inclusive work environment
• Training and development opportunities
• Smart working model (two days per week)
• Competitive reward packages
• Social and company events
• Wellbeing initiatives (welfare)
• Canteen
• Benefits (Pension Fund- Health Insurance)

What we offer?

• This is a full-time job
• The contract is a temporary, one-year agreement
• Salary package range: 35.000/40.000 euro

Do you want to join us? Are you ready to make the difference? We look forward to your application. Please send it to careers@orthofix.com