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Global Quality Audit Manager

Gothenburg, SE

Ref. number:  2141

 

In our daily work, we create unique medical solutions to improve quality of life. We enjoy what we do because it makes a difference in people’s lives – for real. But without the right business-critical team support, we can’t do it.


Although we’re a global company, we’re still small enough for you to make your mark. Our leaders are accessible and trust us to make the right decisions. As a Mölnlycke employee, you’ll thrive when you take on the responsibility.


We offer a permanent position as Global Quality Audit Manager who will be leading audit programs (internal & external) and developing quality methods/policies. In this role you will manage the end to end quality audit process from up front planning to audit closure after corrective actions are implemented. You will ensure a global management of quality audits and create awareness related to quality management. The Global Quality Audit Manager Is the Subject Matter Expert of this process. 

 

Key Accountabilities


•    Act as SME for all Quality Audit processes.
•    Establish, maintain, and continually improve the Global Quality Audit program.
•    Lead and manage the Goteborg Internal Quality Audit program to ensure all audits are done on time.
•    Support external audits around the world at the other Molnlycke sites which includes. 
•    Build and lead a stable of qualified auditors to support all audit programs/activities.
•    Build relationships with many different functional groups and implement product/process improvements/controls to enhance quality across all processes.
•    Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements.
•    Lead the implementation of quality assurance programs designed to meet or exceed internal and external requirements.
•    Lead Quality Audit Meetings.
•    Assist/Interface with audits owners on preparations, scheduling, realization of the audit as well as investigations, action plans, and verification/validation activities.
•    Assure proper root cause analysis for all global quality operations nonconformances.
•    Monitor problem statements, correction, containment, root cause assessments (RCA), corrective actions, preventive actions, time lines, and required updates related to audits both internal and external.
•    Ensure all audit files are established, maintained in a timely & organized manner.
•    Identify & trend appropriate metrics for quality audits. Feed and present those metrics into the RQA leadership team.
•    Lead and manage quality improvement projects.
•    Staying up to date on the current changing regulatory landscape, industry trends, and new regulations by attending conferences and reading various literature throughout the year.


Experience and education


•    Bachelor’s Degree in Science, Engineering, Business, Education, Mathematics, or technical field.
•    Minimum 5 years of experience in Quality Assurance or related field in a regulated industry (Pharma, Medical Devices,Automotive, Aero space, etc.). Medical Device experience preferred.
•    Minimum of 2 years of direct quality audit experience leading a team of employees.
•    Direct external regulatory audit experience and knowledge (FDA, TGA, ANVISA, MHRA, etc.).
•    Direct experience supporting and/or leading third party ISO audits.
•    Extensive knowledge of MDSAP, ISO 13485, and 21 CFR 820.
•    Superior leadership, facilitation, and communication skills.
•    Demonstrated implementation of continuous improvement methodologies.
•    Good report writing and reviewing skills.

 

Desired Qualifications


•    ASQ Certificate: CMQ&OE, CQE, CQA, CQT, CBA, etc.
•    Lead Auditor Certification and Training.
•    Operational Excellence/Six Sigma/Lean training or certifications.
•    Project management certifications (Black Belt, Green Belt, Certified Associate in Project Management (CAPM), Project Management Professional (PMP), etc).
•    Experience using Mastercontrol and/or SAP.

 

Closing date for applications is 8th of February, but we have an ongoing review of candidates. We will contact only selected candidates.


About Mölnlycke


Mölnlycke is a world-leading medical solutions company. We design and supply solutions to enhance performance at every point of care – from the hospital to home care, proving it every day. 
We specialise in: 
•    Wound management: including dressings with Safetac® such as Mepitel® and Mepilex®
•    Preventing pressure ulcers: with Mepilex® Border used prophylactically and devices to help turn and re-position patients
•    Surgical solutions: including Mölnlycke trays, HiBi® antiseptics and Biogel® surgical gloves
Mölnlycke was founded in 1849. Nowadays our solutions are available in around 100 countries; we’re the number one global provider of advanced wound care and single-use surgical products; and we’re Europe’s largest provider of customised trays. Our headquarters are in Gothenburg, Sweden and we have about 7,800 employees around the world.