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Logistics Quality Supervisor - Anderson, SC

Andersen, SC, US

Ref. number:  1054

We care about making people better – those we work for, and those we work with. And we prove it every day.     


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.   


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’re now looking for a Logistics Quality Supervisor to play an important role in our Operations function. What makes you stand out is your passion for what your work means – coupled with your ability to listen to customers and respond with appropriate urgency. 


The Opportunity:


The Logistics Quality Supervisor is responsible for the implementation and operation of the Quality Management System at the Mölnlycke Anderson, SC Distribution Center facility. The Logistics Quality Supervisor works closely and proactively with other department managers and provides managerial team guidance on compliance. During  inspections and audits, the Logistics Quality Supervisor is the primary contact person with visiting authorities for Quality.  This position also interacts with customers, hosting customer audits, codifying specifications and handling customer complaints.  


In addition:

  • Responsible for implementation of a Quality System focused on Logistics activities which complies with the requirements of 21 CFR Part 820 and applicable Quality System standards (i.e... ISO 13485). 
  • Support key Logistics operational activities as part of local Quality Management system and continuous improvement tools.
  • Function as the resident expert and advisor on 21 CFR part 11, 803, and 820 and ISO 13485.  Also provide guidance on compliance to current ISO standards for 14001, 14644 and 14971. 
  • Function as the primary contact for FDA and Foreign Regulatory Authority inspections.   
  • Ensure all employees are trained on the Quality System Regulation and understand their role in compliance. 
  • Exercise the authority and responsibility to stop processing, suspend operations, quarantine and control nonconforming material, components and finished goods. 
  • Interact globally with other Quality colleagues by collaborating on improvement activities and sharing best practices. 
  • Function as direct link between the Global QA Team and the local site to ensure local strategies are developed and aligned in a way that supports the global strategy. 
  • Supervise and plan Quality Assurance Department resource requirements. 
  • Plan and execute the department's annual budget.
  • Routinely observe and periodically conduct internal audits on all aspects of operations. 
    Proactively ensure that the company is meeting customer specifications and expectations. 
  • Work directly with HR to ensure a local training program for all employees is implemented that fully meets Quality System requirements. 
  • Consult with other department managers to ensure all Quality System requirements are met within their departments. 
  • Create and execute employee development plans that improve the departments effectiveness. 
  • Leads the effort to implement best practices within job scope; expected to participate in activities designed to improve production, quality and Environment, Health, and Safety (EHS). 


Key Decisions:

  • Act as Management Representative for the Anderson site per 21 CFR 820(b)(3) and ISO 13485.
  • Decisions in quality system requirements to be implemented, e.g., procedures, processes, policies, and tools as part of QA Logistics and Supplier Quality Assurance
  • Reviews applicable standards and regulations and determine if there are any exclusions.
  • Identify processes needed for the QMS and their application throughout the site and as related to role.
  • Determine the sequence and interaction of these processes.
  • Plan how to monitor measure and analyze the processes.
  • Determine and implement actions necessary to achieve planned results.
  • Release or reject/block products in case of deviation from specifications or supplier agreements.
  • Supplier complaint management follow-up
  • Determine annual budgetary requirements for the department.
  • Supervise, train, develop and support the local QA Engineer as part of daily activities.
  • Work closely with external manufacturing to support achievement of Molnlycke Quality standards.


Education and Experience:

  • BS/BA in related field or an equivalent combination or education and experience
  • 4 years quality management experience within the medical device or pharmaceutical industry required. Supervisory experience a plus.
  • Strong leadership skills and experience in directing and developing teams.
  • ISO 13485 or ISO 9001 lead auditor certificate          






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.    


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.