Senior Quality Engineer

Dedicated to stoma care  

Location: Ballina 
Department: Quality 

Senior Quality Engineer, Ostomy

Summary:

The role  involves working in a broad range of Quality Engineering disciplines, with particular focus on Validation and Compliance. The successful candidate will work closely with Engineering, Manufacturing and Continuous Improvement functions.

Responsibilities:

• Manage Change Control Requests as a quality resource
• Planning, coordinating, executing, documenting and performing pFMEA, Validation Studies, process capability studies and process improvements
• Participate (by reviewing and evaluating impact) in the disposition of non-conforming material decision-making process.
• Co-ordinate the Ballina Ostomy QMS processes e.g. customer complaints system, CAPA system and internal audits. 
• Develop Quality Plans and work instructions, documenting procedures
• Support strategic projects aligned with Plant QA, Global Supplier Quality, Plant Operations and Global Engineering 
• Conduct defect awareness training sessions
• Participate in internal/external audits

Essential functions of the role:

• Knowledge and application of basic statistics
• Knowledge of Risk Based Validation 
• Good Communication skills, both written and oral
• Strong technical writing skills 
• Ability to train/facilitate
• Knowledge and implementation of medical device Quality System requirements (FDA and ISO) and Good Manufacturing Practice preferred
• Knowledge of Lean and Six Sigma principles 
• Ability to achieve results through working with cross functional teams 
• Proficient computer skills, including Microsoft Office Suite (Word, PowerPoint, Project, Access, and Excel), Minitab

Education/Work Experience Requirements:

• 5-8 years of experience in Quality Engineering or equivalent industry disciplines
• Experience in medical device manufacturing regarding Quality System requirements per 21 CFR 820 and/or ISO 13485 preferred
• Degree in Engineering/Science Discipline or related study

Dansac has been providing innovative solutions for people with a stoma, clinicians, and caregivers for more than four decades. The company was founded in 1971 in Fredensborg, Denmark. Since then, Dansac has become part of Hollister Incorporated, which is located in Libertyville, Illinois, USA.  At Hollister and Dansac, we are passionate about the work we do, and we are committed to making life more rewarding and dignified for our Associates and for the people who use our products and services. A career at our company can take many paths, all of them leading to rewarding opportunities.