Job Description

Make your next move matter

Are you ready to challenge yourself and make a real impact?

Do you want a career that impacts millions of people for the good? At Mölnlycke, you’ll be helping to equip medical professionals with solutions to improve outcomes for patients. And you’ll develop your career in a growing organization with an inspirational culture – where you’ll be recognized for the results you’ve achieved.

Mölnlycke is now looking for a Senior QA Engineer to lead customer complaint management and oversee the end-to-end control of Non-Conformance (NC) and CAPA processes within the MasterControl system. The role ensures strong quality governance across site operations, maintaining compliance with ISO 13485, MDSAP, FDA 21 CFR Part 11, EU MDR, and internal standards.

Where You’ll Make a Difference

In this role, you’ll contribute to meaningful work that improves lives. You’ll collaborate across teams, bring your ideas to the table, and help shape solutions that matter. Whether you’re streamlining a process, launching a product, or supporting a colleague, you’ll be making a difference everyday.

Here’s how you’ll make an impact in this role:

• Manage routine and non-routine Complaint Handling of products.
• Execute local procedures of Customer Complaint and adhere to departmental key performance indicators and organizational requirements
• Organize meeting with respective functional team members for root cause analysis and establishment of Corrective and Preventive Actions for customer complaint
• Review outstanding tasks daily, follow-up the updates status of testing results and investigation outcomes to ensure closure of tasks and action items in MasterControl
• Prepare and update customer complaint reporting including Monthly Complaint Trend, Pareto Charts and Data Analysis on the breakdown of complaints
• Follow up on Verification of Effectiveness for actions taken on customer complaints till closure
• Track recurrence of confirmed complaint within a year and issue A3 format (8 Steps RC) for recurrence complaint and follow up till closure
• Manage the filing, scanning & verification and archiving the customer complaint records which include DHR, internal retained samples and customer returned samples (storage and disposal where appropriate)
• Manage Nonconformance (NC) and CAPA Initiation, Risk Assessment, Investigation and Action Items till closure with adequate objective evidence of Verification of Effectiveness
• Direct support as Subject Matter Expert during internal and external audits (Internal Auditing, Corporate, BSI, FDA, Customer, Unannounced, Accreditation Body)
• Deputize Quality System Manager when he/ she is unavailable or away.
• Carry out process and system audit as assigned by the management
• Any specific responsibilities with respect to multiple management systems of ISO 14001, ISO 45001, ISO/IEC 17025 relating to documentation and records management.

• To ensure all QA activities related Customer Complaint, NCP& CAPA, Document Control and Internal Auditing are compliance to Quality System Requirements, MDSAP, US FDA 21 CFR Part 11, ISO13485: 2016, EU MDR and other relevant site / global standards.
• To provide support and recommendations to manufacturing / operation personnel on Quality System Requirements in day-to-day operations.
• To allocate responsibility to subordinates according to job functions and expertise.

What you’ll need:

• Degree in Engineering or major science equivalent

• 3 - 5 years of direct working experiences in Quality Assurance (QA) functions in medical industries
• Good interpersonal skills, systematic approach in executing the jobs / assignments, strong / good organizing ability, dynamic personality.
• Computer literacy is an added asset.
• Experience with ISO/IEC 17025 accredited laboratory environment is an added asset

Capabilities

• Knowledge of QSR, CFR, cGMP, and ISO regulations (required)
• Analytical and strategic skills.
• Regulatory requirements & standards for medical devices.
• Product / Process knowledge.
• Management/Managing skills.
• Problem solving / analytical skills.
• Interpersonal and supervisory skills

Our approach to Diversity & Inclusion

We’re building a workplace where everyone feels seen, heard, and valued. We believe that a diverse mix of people (from different cultures, ages, geographies, and genders) makes us stronger. It brings fresh perspectives, drives better decisions, and helps us deliver solutions that reflect the world we serve.

Inclusion isn’t just a value, it’s how we work, grow, and lead together.

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 8,700 people. The company headquarters are in Gothenburg, Sweden and we operate in more than 100 countries worldwide. Mölnlycke is a founding partner of GoCo Health Innovation City, a world-class innovation cluster for health.

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