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Quality Manager ( Anderson SC)

Andersen, SC, US

Ref. number:  4903

Are you passionate about making life better for patients worldwide?

If the answer is yes, you think just like us! We’re Mölnlycke, a global leader in the design and supply medical solutions. More importantly, we put patient care first! We’re looking for people who want to improve outcomes for healthcare professionals and their patients. 

 PURPOSE OF POSITION

The Quality Manager is responsible for the design, implementation and operation of the Quality Management System at the Anderson Distribution Center. In this role the QA Manager work closely and proactively with other department to ensure their regulatory responsibilities are met and provides managerial team guidance on compliance, interface with their global colleagues to ensure harmonization of acceptance activities with critical partners and coordinates corrective actions between the sites and act as the Management Representative.

The QA Manager is also responsible for the evaluation of Americas Logistics suppliers and Americas contract manufacturers, organizes suppliers audits and ensure continuous evaluation of suppliers to ensure their operation under a compliant and robust QMS in alignment with Molnlycke QMS and applicable regulatory standards.

 

KEY ACCOUNTABILITIES

  • Ensure that quality system requirements are effectively established and effectively maintained in accordance with 21 CFR 820(b)(3) and ISO 13485
  • Report on the performance of the quality system to management with executive responsibility for review in accordance with 21 CFR 820(b)(3) and ISO 13485.
  • Consult as the primary resource at the site for all departments on regulatory compliance, ensuring each department manager understands and complies with the requirements in 21 CFR 820 and applicable Quality System standards, and manage adequate training for employee
  • Function as the primary contact for FDA and Foreign Regulatory Authority inspections. 
  • Ensure block / release / Traceability / recall requests in order to support factories, product complaints team and Regulatory Affairs.
  • Supervise, train and develop the Quality Assurance Engineer in their daily operations and personal development journey.
  • 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.
  • 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.
  • 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).
  • Manage and execute internal audit system.
  • Manage and lead supplier evaluation process for Americas-based suppliers (Logistics suppliers and contract Manufacturing): Organize and lead supplier audits for Americas Logistics and support global supplier audit program.
  • Support, make improvement proposal and apply the Global SQA process for Contract Manufacturing Americas-based, with a focus on release process and incoming inspection.
  • Lead or participate in CAPA / FMEA / risk analysis and other failure investigation activities related to Americas Logistics, contract manufacturers, or other suppliers in cross-functional teams.

QUALIFICATIONS 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 is a plus.
  • Strong leadership skills and experience in directing and developing teams.
  • ISO 13485 lead auditor certificate

Mölnlycke is a world-leading medical solutions company. We design and supply medical solutions to enhance performance at every point of care – from the hospital to the home.   

We specialize 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 customized trays. Our headquarters are in Gothenburg, Sweden and we have about 7,800 employees around the world.