![Hollister Incorporated](https://media.trabajo.org/img/noimg.jpg)
(Urgent) Senior Quality Engineer
2 weeks ago
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
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