Quality Assurance Engineer
Be a part of the future of healthcare- Not only a career but the opportunity to make a difference by “CREATING VALUE BY HELPING PEOPLE”.
If you are interested in transforming the healthcare sector worldwide, Q3 Medical will fulfil your needs for both personal and professional growth. We are a growth stage commercial company which is leading innovations in biodegradable implants and micro invasive technology for the Interventional Radiology, Gastro Intestinal, and open Surgical procedures which will change the face of healthcare, offering better clinical outcomes and reducing the overall cost of care.
Describe the role:
We are looking for a Quality Assurance Engineer to join our highly motivated team. The right applicant would be helping improve the lives of patients around the world by driving the quality and reliability of our innovative products.
Our Quality team ensures compliance of the Global Quality Management System (QMS) with applicable Medical Device standards and regulations with the purpose of guaranteeing that our work is meeting the high demands of our customers, but also the patients who are relying on them. As a quality engineer focussed on complaint handling you will play a critical role in upholding our commitment to excellence and customer satisfaction. You will be responsible for managing and investigating products complaints, identifying root causes, and implementing corrective and preventive actions to ensure continuous improvement in our medical devices´ quality.
If you are passionate about growing a quality driven culture throughout our organisation, ensuring the safety and reliability of our medical devices and resolving issues with utmost precision then we encourage you to Hit Apply!
Location: Winsen, Germany
What is the Day Job:
Complaint Handling:
· Receive and register customer complaints, maintain complaints log/register, investigate complaints, write reports, and update customers on complaint outcomes, and conduct monthly complaint meetings.
Adverse Event & Incident Reporting / Regulatory Notification:
· Provide support to PRRC by collecting information on adverse events, performing investigations, and preparing Incident/Adverse Event Reporting reports.
· Assist PRRC in submitting Incident/Adverse Event Reports & supporting documents to regulatory
NCR Handling and CAPA:
· Manage NCR activities, including initiation, scope, investigation, risk management disposition of product, corrections, and closure, execute NC activities, complete NC reports with proper documentation, and maintain the NCR log/register.
· Manage and complete all CAPA activities when necessary.
What you need:
· Bachelor’s Degree in Medical Science or Engineering
· Minimum 2 years in a quality engineering role with specific experience with complaint handling in the medical device industry
· Strong understanding of quality management systems (ISO 13485) and regulatory requirements.
· Proficient in conducting investigations using various quality tools and methodologies (e.g. CAPA).
· English language fluent, German is preferred to communicate with our manufacturing employees
· Excellent analytical and problem-solving skills, with meticulous attention to detail.
What we would like:
· Experience in the use of statistical tools (e.g. Mini Tab, SPC etc.)
· Focus on results with a growth mindset
· Excellent communication and presentation skills with ability to communicate in all directions and teamwork skills
· Process improvement orientated with a Can-Do mentality
What We Can Offer:
· Friendly and open-minded working atmosphere
· Flexible working hours
· Training and career development, with onboarding program for new employees
At Q3 we are dedicated to building an inclusive, diverse and authentic workplace so if you think you have the relevant experience, skills and knowledge but it doesn’t line up with the description we would love to hear from you regardless. Please do not be shy- You might just be the candidate we are looking for. Q3 Medical is an equal opportunity employer.
Life at Q3 Medical
Whilst our company was founded 25 years ago, it is still in its infancy. We have challenged ourselves to become a global leader in creating and producing medical technology that truly is “CREATING VALUE BY HELPING PEOPLE”
We have created an incredible sustainable culture to guide us into the future where we continue to value innovation and growth including the personal and professional our people as well. We are dedicated and loyal to our mission and each other to insure we act and feel part of the Q3 Family. Our leaders are inspiring and always look to lead individuals, teams and the company with empathy which is the foundation for our success. We encourage our employees to be there best and embrace their diversity and everything they have to offer to develop them to help us be life changing as well.
Our team is a diverse set of incredible people who bring their individual experiences, backgrounds and ideas to life every day. We believe the only way to fulfil our mission is to attract forward focused and talented people to be a part of our collective journey. We are constantly looking for well-rounded doers around the world to join our diverse team represented by almost 30 different countries who not only share what we have created in our foundation but also have the capability to develop it future through innovation, loyalty and empathy.
The more people we help whether that be patients, doctors, customers or employees the more value we create. This is our commitment to our vision of “CREATING VALUE BY HELPING PEOPLE”.
Art der Stelle: Vollzeit
Gehalt: 48.000,00€ - 54.000,00€ pro Jahr
Arbeitszeiten:

• Montag bis Freitag

Leistungen:

• Firmenevents
• Flexible Arbeitszeiten
• Kostenloser Parkplatz

Arbeitsort: Vor Ort