Quality Systems Engineer

Medartis Inc. - United States; Warszawa; On-site; PLN 327,000 - 462,000; Full time

Job summary

Medartis seeks a Quality Systems Engineer to support the Quality Management System, quality assurance and continuous quality improvement across the organization. The role focuses on CAPA administration, audit activities with the Notified Body and customers, and KPI data management.

You will assist QMR in annual reviews, develop procedures, and ensure controls and documentation comply with ISO 13485:2016 and regulatory requirements. Join a global medtech leader in orthopaedics.

Qualifications

• BS in Engineering or related field preferred, or equivalent experience
• Working knowledge of medical device regulations (ISO 13485; FDA 21 CFR 820)
• Basic knowledge of statistics and engineering principles
• Strong analytical and problem-solving skills
• Proficient with MS Office applications

Responsibilities

• Act as CAPA administrator by facilitating CAPA system and leading CAPA review board meetings to ensure compliance
• Manage external audit activities including certification audits and customer audits, liaising with external parties and reporting metrics
• Facilitate all internal audit activities: planning resources, scheduling, and reporting metrics
• Gather and manage KPI/metric data used to measure the QMS
• Assist Quality Management Representative (QMR) in conducting annual quality management reviews per ISO 13485:2016
• Create and update procedures and work instructions to capture improvements to QMS processes
• Assist subject matter experts in development, authoring and releasing procedures and work instructions for their processes
• Maintain document controls and change controls within the QMS
• Ensure processes and documentation comply with quality system regulations

Skills

Analytical skills

Problem solving

Root cause analysis

Statistical principles

Engineering principles

Education

BS in Engineering or related field

Tools

Microsoft Office

Job description

At Medartis, we combine innovative solutions with skilled professionals to be the provider of choice in orthopaedics. Founded in 1997 and headquartered in Basel, Switzerland, the Medartis Group is one of the world’s leading manufacturers and providers of medical devices for the surgical fixation of bone fractures in the upper and lower extremities, as well as the craniomaxillofacial region. The company employs around 1,400 people across its 13 locations and sells its products in over 50 countries worldwide.

The Quality Systems Engineer contributes to the Quality Management System team in the functional areas of quality systems, quality assurance, and quality improvement.

Your Responsibilities

• Act as Corrective Action/Preventive Action (CAPA) administrator by facilitating the (CAPA) system. This includes initiating CAPA's, overseeing timelines, managing the CAPA log, reporting CAPA related metrics and leading CAPA review board meetings to ensure compliance.
• Manage external audit activities including certification (notified body) audits and customer (contract manufacturing) audits. This consists of taking an active role in the audit process, as well as acting as liaison with external parties, scheduling audits, organizing and facilitating resources, communicating audit responses, maintaining the audit schedule and reporting all audit related metrics.
• Facilitate all internal audit activities. This includes planning, assigning resources, managing the internal audit schedule, and reporting audit related metrics.
• Gather and manage KPI/metric data used to measure the QMS.
• Assist quality management representative (QMR) in conducting annual quality management reviews per ISO 13485:2016.
• Create and/or update procedures and work instructions to capture improvements to quality management system process'.
• Assist subject matter experts in the development, authoring and releasing of procedures and work instructions used to define their processes.
• Understand, utilize and assist in maintaining document controls and change controls within the QMS.
• Ensure processes and documentation comply with quality system regulations.

Your Qualifications

• BS in Engineering or related field preferred, or equivalent in experience and training
• Working knowledge of the medical device regulated industry, to include ISO 13485 and FDA 21CFR820 regulations
• Basic knowledge of statistical and engineering principals
• Strong analytical and problem solving skills
• Strong proficiency in root cause analysis to include tools and methodology
• Proficient in Microsoft Office applications

This is an integral, responsible and diversified role with a focus on quality and service provision in a rapidly growing, international company.

For further information please visit our Website www.medartis.com.

Medartis

Human Resources

T [phone]

www.medartis.com