Quality Systems Engineer

solique ag; Warsaw (IN); On-site; USD 90,000 - 120,000; Full time

Job summary

Medartis is seeking a Quality Systems Engineer to support the Quality Management System across QA and quality improvement functions. You will drive CAPA processes, prepare and respond to audits, and help maintain ISO 13485 compliance.

The role requires strong analytical and problem-solving skills, knowledge of CAPA, and experience with QMS documentation and change controls in the medical device industry.

Qualifications

• BS in Engineering or related field or equivalent experience.
• Experience with ISO 13485 and FDA 21 CFR 820.
• CAPA administration, internal/external audit support, and QMS documentation.

Responsibilities

• Act as CAPA administrator and lead CAPA reviews.
• Manage external audit activities and liaise with Notified Bodies.
• Coordinate internal audits and report audit metrics.
• Gather KPI data to measure the QMS.
• Assist QMR with annual quality management reviews per ISO 13485:2016.
• Develop and update quality procedures and work instructions.
• Maintain document and change controls within the QMS.
• Ensure compliance with quality system regulations.

Skills

Analytical skills

Problem solving

Root cause analysis

Microsoft Office

Education

BS in Engineering or related field

Tools

CAPA system

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.
• 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

What we offer

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

What we offer

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 .