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T&P Quality Engineer/Supervisor

Wiscasset, ME, US

Ref. number:  2554

The strong culture within Mölnlycke is one of the reasons why we as a company have become a world leader. We need to keep building on our strong culture and constantly improve our performance to meet the increased competition and demands on the heath care market. That is how we, as employees, act.

Integrated in the High Performance Behaviors are the core values passion, learning and integrity, which are highly valued by many and part of the reason for our unique culture and our successful achievement so far.

  • Customer at Heart
  • Appropriate Urgency
  • Own the Outcome
  • Teamwork

 

We are currently hiring a Quality Engineer/Supervisor in our Wiscasset, ME location! In this role you will proactively support manufacturing and customer requirements regarding the quality system issues and discrepancies under the direction of the Quality Manager.

 

This position is responsible for supporting the design of quality controls which ensure our products meet specification. You’re also responsible for coordinating the CAPA, NC and Customer Complaint program, making continuous improvements internally and following up on corrective actions to evaluate their effectiveness.

 

Additionally this position is responsible for the supervision of the Quality Laboratory personnel. 

 

RESPONSIBILITIES

  • In conjunction with the QA technicians for Turning & Positioning products, support the day‑to‑day QA activities and coordinate with Manufacturing Supervisors on the planned production schedule
  • Ensures all in-process and final testing of processed components for contract manufacturing (i.e. Heel Boot to iiMed) and medical devices are complete prior to releasing for shipment.
  • Ensures raw material incoming inspection tests are performed as required. 
  • Designs quality controls for production processes which ensure specifications are met through objective measurement.
  • Assists with the coordination of cross training activities for Quality Assurance Technicians in both business units in Wiscasset.
  • Maintains attendance records and approves time cards/sheets for T&P QA lab technicians
  • Assists with development and implementation of new procedures, standards, and specifications as required by ISO Quality Management Systems as well as 21 CFR Part 820.
  • Maintains and reviews quality documents for accuracy and compliance with 21 CFR Part 820 and ISO 13485 requirements and standards.
  • Monitors changes to standard operating procedures and makes recommendations for improvements to those processes.
  • Coordinates continuous improvement projects to keep them on schedule and meet objectives.
  • Interfaces with internal staff to resolve quality system Issues and complaints.
  • Creates/generates standard and ad hoc reports regarding product quality.
  • 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.
  • Performs other duties as assigned by manager

 

QUALIFICATIONS & EXPERIENCES

  • 5 years of relevant experience in a laboratory setting working in a Quality related field
  • Minimum 2 years of experience with ISO 13485 Quality Management System Management that is compliant with 21 CFR Part 820
  • Associates Degree in a technical field; Bachelor's degree in the Sciences or Engineering preferred
  • Medical Device Manufacturing experience and/or Project Management experience
  •  a plus!
  • Prior supervisory experience desirable

About Mölnlycke  

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.  


Nearest Major Market: Maine