QA Product Development Engineer

Do you want your impact to be recognised?
If you’re ready to have an impact in a career that makes a difference, Mölnlycke could be your next step. You’ll be helping to equip medical professionals around the world with solutions to improve outcomes for patients. And you’ll be developing yourself in a global environment with an inspirational culture, with lots of opportunities. All the while building a successful career, with real purpose.
Looking for an inspirational environment to take your next step?
As a QA Product Development Engineer, there is great opportunity and variety in activity day to day.
You’ll be our knowledge expert in New Product Development projects as well as life cycle management activities to give QA-guidance and support to assure compliance and safe products are developed and released.
It will be your responsibility to pro-actively support and advice the applicable BAs and functions in design control and change control activities according to quality management system (QMS).
In this role you are supporting our organization in addressing quality issues that can jeopardize compliance to product development and life cycle management processes (Design Control, Change Control, Risk Management, Post Market Surveillance or related processes).

You’ll be responsible and make a significant contribution to;
Ensuring that Design Control, Change control and risk management (including related processes) processes are followed during product development projects and product changes
Review and approve or reject relevant product related technical documentation for completeness and compliance according to QMS requirements and applicable regulation;
Support in root cause analysis of quality issues for design control or change control or related and as well as giving input to effective corrections, corrective actions and preventive actions
Function as source/reference point for quality information and coach applicable Mölnlycke organisational roles and positions in QMS requirements
Participate in external, corporate, local or any internal audit activities to support audit programs.
Provide feedback on the applicability and adherence to QMS processes during execution of new product development projects and life cycle management activities within the areas of Design Control, Change Control, Risk Management, Post-Market surveillance and related sub-processes.
Ensure right QA competence involvement at the right time in design control or change control related activities and questions


We’ll give you the challenges, skills and support to advance your career. You will join a team of like-minded specialists who are driven by excellence and delivery.

What’s in it for you?
Aside from getting involved with the rewarding projects mentioned above and advancing your own skillset, you will also benefit from the following:
Achievable annual bonus
Health Insurance
Private Pension
Wellness contribution
Products and services benefits discount platform
Genuine career longevity and professional development opportunities
Plus regional specific benefits


If all that sounds appealing then here is what we would like you to demonstrate:
Academic background in engineering, life sciences, medical biology, chemical area or other relevant area.
Minimum 2 years of experience from medical device industry or equivalent
Working experience within the product development/Life cycle management area preferable within the areas of Quality or R&D.
Knowledge in applicable quality system regulation e.i. ISO 13485, MDD/MDR, FDA 21 CFR part 820 and ISO 9000
Experience from work in an international organization or environment
Analytical Skills
Fluent in English and preferable Swedish


Your work-life balance
The placement of this position is flexible, meaning that you can be situated close to our headquarter in Gothenburg or across the EMEA region, near our regional hubs.
The job does not require extensive domestic and international travel
Remote working


If this sounds like you and you feel you have what it takes to succeed in this role, we want to hear from you!
www.molnlycke.com/careers

About Mölnlycke
About Mölnlycke Mölnlycke is a world-leading medical products and solutions company that equips healthcare professionals to achieve the best patient, clinical and economic outcomes. Our business is organised in the four business areas Wound Care, Operating Room Solutions, Gloves and Antiseptics, where customer centricity, sustainability and digitalisation are at the heart of everything we do. Mölnlycke employs around 8,400 people. The company headquarters are in Gothenburg, Sweden and we operate in more than 100 countries worldwide. Since 2007, the company has been part of Investor AB, an engaged owner of high-quality, global companies which was founded by the Wallenberg family in 1916. For more information, please visit www.molnlycke.com and www.molnlycke.com/careers