Telephone: 086 8395533
Senior Sterility Assurance Engineer
Our client, a medical device company in Galway are currently looking to recruit a Senior Sterility Assurance Engineer for their site.
About the role:
- Develops, establishes and maintains sterilization assurance programs, policies, processes, procedures and controls ensuring that performance and quality of products conform to established standards and agency guidelines.
- Reviews, analyses and reports on quality discrepancies related to process and product systems and develops disposition and corrective actions for recurring discrepancies.
- May interface with manufacturing, engineering, vendor and subcontractor representatives to determine responsibilities and solutions.
- May serve as liaison between the company and the various governmental agencies.
- Works directly with operating entities to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications.
Your responsibilities include:
- Establishes and promotes a work environment that supports the Quality Policy and Quality System.
- Ensures that all Sterilization processes are validated to required International standards and are in maintained in a State of compliance.
- Identifies and implements effective Sterilization systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external quality and regulatory requirements.
- Manages and provides oversight on Sterilization related CAPAs.
- Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving Sterilization related issues.
- Manages potential improvements and VIP opportunities within the Sterilization work stream.
- Provides project direction, coaching, development and mentoring for sterilization and technical team personnel.
- Participate in the planning for and execution of Sterilization requirements for Integration and Acquisitions.
- Contributes to the development of Sterilization Standards through relevant working groups.
- BS in Science/Technical Field.
- 8-10 years of related experience, 5-7 years in the medical device industry preferred.
- Proficient with Microsoft Office Suite and Minitab
- Excellent communication and presentation skills.
- Subject Matter Expert for FDA, ISO, MDD and and/or quality requirements associated with developing medical devices.
- Subject Matter Expert for International regulations associated with all modes of sterilization.
- Demonstrated expertise in ethylene oxide, Gamma and E beam sterilization processes with a working understanding of other sterilization methods.
- Demonstrated proficiency in providing coaching, development and mentoring for sterilization team personnel.
- Pro-active, energetic, self-assured professional with high personal integrity and ability to collaborate, influence and develop positive interpersonal relationships.
For further information on this Senior Sterility Assurance Engineer role in Galway please contact Bimi Felix on 086 8395533 / firstname.lastname@example.org
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