Manager Process Excellence & Risk

We are now recruiting for a Manager Process Excellence & Risk who is responsible for the oversight and maintenance of QPEM Programs across all Mölnlycke Health Care facilities. The preferred location for this role is the Mölnlycke Health Care HQ in Gothenburg.
Job Purpose:
On Process Excellence:
On a global level drive cross-functional process excellence within the Quality processes (System & Assurance).
Develop and manage roadmap, ensuring alignment with the Quality and agreement on prioritization.
Take lead in driving the strategic directions for Quality processes in collaboration with the management teams of Regulatory, Supply Chain, QSystems, QA Commercial, Operations and IT.
Promote and establish arenas for cross functional collaboration and improvements.
Use LEAN methodology to provide improvements and remove waste
Implement LEAN in a results oriented way
USE process excellence as daily management
Identify core value drivers to measure progress
Apply value stream mapping techniques
Standardize and sustain work processes
Together with the functional management teams and key users identify areas of improvements.
Develop and drive governance process for QS/QA globally, ensuring global policies/standards being developed and maintained.
Identify skill development needs and trainings required to reach the strategic goals.
Guide and support the operational departments in their efforts towards process excellence aligned with the company strategy and end-to-end priorities.

On Risk:
Leads the risk lifecyle management process throughout the development cycle, ensuring that risks are identified, control measures are defined, verified and effective.
Assures presence of product-related files and reports) that support compliance efforts and enhance product safety and performance.
Reviews post-market surveillance data and competitive products, including complaint data and publicly available adverse event databases (e.g. MAUDE, Eudamed) to anticipate potential issues and bring awareness to all appropriate stakeholders.

Overall:
Support development of QS/QA enablers as visibility tools and performance metrics.

Accountabilities:
Periodically perform organizational reviews to ensure efficient use of resources and make adjustments as necessary to ensure the department is properly focused.
Participate and assist in due diligence activities as required representing the Quality function.
Work with Global Team partners to share best practices and transfer that knowledge globally to facilities that can benefit from them

Process Excellence:
Prepare and manage a 5 year roadmap for the global QS/QA fulfilment processes in line with the RQA roadmap and in collaboration with the management teams of RQA.
Establish standards
Assess process management maturity within QS/QA.
Visualise the “heat map” of RQA (management maturity and performance).
Identify areas of improvements using QS/QA performance KPIs and the above mentioned “heat map”.
Prioritize and propose areas and sequence of improvements of QS/QA processes.
Drive global standardization of QS/QA processes including the development and monitoring of related KPIs using LEAN methodology and core value drivers.
Ensure global standards being documented. Select and use effective process documentation tools and ensure that process maps and documents being updated.
Define reference points and tolerances of QS/QA KPIs.
Identify and implement QS/QA process performance measure.
Governance structure to manage standards
Act as RQA subject matter expert, supporting projects and project managers, direct questions to functional or process SME still ensuring the development of global standards being respected.
Challenge and improve standards
Initiate and establish best practice sharing within different areas of the QS/QA processes.
Lead cross functional value process mapping and development initiatives identifying areas of improvements that needs to be addressed to improve the QS/QA process performance.
Together with stake holders conduct pre-studies on consequences of systems and tool changes to QS/QA processes
Support functional excellence Capability building Identify business trends and best practices to be updated and aware of trends and possibilities.
Evaluate applicability to Molnlycke.
Capability development – participate in the design of skill and training / development programs when needed in order to ensure alignment with strategy and process development needs

Risk Management:
Provides leadership and expertise to product development teams at a system level and within engineering disciplines to ensure risk management principles are applied throughout the design process.
Assesses product non-conformities and provides sound risk/benefit rationale for deferred defects.
Provides product risk expertise input to Health Hazard Evaluations (HHEs) to improve responses to issues in the field;
Performs risk-benefit analysis and assesses and improves the risk management process resulting in improved overall product safety.

Qualifications, Skills & Experience:
Essential:
Academic degree in scientific area. A business degree is advisable
Minimum 5 years in Regulatory Affairs and Quality Systems, preferably in different environments
Experience with LEAN, 6 sigma and other improvement tools
Experience in working with ERP, BI and/or APS systems
Willingness and ability to travel
Change management
Desirable:
RQA management experience
Value stream improvement experience
Knowledge on SCOR
Leader Auditor certification

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 the home proven 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.