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Quality Assurance Validation Engineer

Wiscasset, ME, US

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

Purpose of the Position:

Design and develop and maintain robust validation system in order to fulfill QMS requirements and support systematic and efficient development work in the area of process validation.  Function as the validation system owner.


Key Accountabilities:

  • Provide guidance on best practice for validation activities.
  • Function as a process validation and equipment qualification subject matter expert for resolution of deviations, assessment of change orders and other quality system actions.
  • Plan, conduct, supervise, document and report Process and Software Validation activities in order to maintain process and software validation documentation in compliance with local and corporate validation procedures.
  • Interface directly with key functional groups internal and external to the local site to obtain the necessary information and support for development of validation protocols (IQ, OQ, PQ).
  • Supervises and monitors equipment and system suppliers in the area of equipment / system qualification to comply with MHC requirements.
  • Collate all data associated with a validation (IQ, OQ, PQ) and compile the final validation report for approval.
  • Maintain the site Validation Master Plan and perform periodic process review and re-validation to ensure continued compliance.
  • Verify that that validation studies have been adequately recorded and documented in accordance with the approved Master Validation Plan(s) and Validation Protocols.
  • Maintain all validation documentation in accordance with site Quality System Requirements.
  • Ensure that all deviations to protocols and/or deviations to acceptance criteria are adequately justified, documented and fully addressed.
  • Define appropriate statistical methods for all validation activity.
  • Conduct validation training and qualify personnel conducting validation activities.
  • Member alt. chairman of the local validation team.
  • Support production with trouble shooting.
  • Supports the effort to implement best practices within job scope; expected to participate in activities designed to improve production, quality and Environmental, Health and Safety (EHS).
  • Perform other duties as assigned by manager

Key Competencies:

  • ISO 13485, 21 CFR 820, GAMP, GMP
  • Statistical methods
  • Process validation
  • MHC product development process
  •  Excellent planning and coordination skills, a plus
  •  Ability to adapt to changes in priorities and project    schedules.
  • Excellent problem solving skills


Qualifications and Experience:

  • Bachelor’s Degree preferred
  • 3-5 years experience in writing and reviewing process validation / equipment qualification in a FDA regulated environment preferred.

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.  

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status

Nearest Major Market: Maine