A Head of Quality Engineering is required by CareerWise Recruitment for our Athlone based client. Responsible for support of quality engineering activities within the plant. In addition, required to provide quality engineering leadership on multiple cross functional project teams. The Head of Quality Engineering will be responsible for providing input and critical review and approval of all validation activities at the plant. Will also have responsibility and authority to service, co-ordinate, direct and control manufacturing quality engineering support and calibration activities. Assists in steering quality improvements within the plant working closely with all departments in the implementation of same.
Please contact Tom Devaney for more information.
Role of this position
- Manages quality systems within the plant which are necessary to meet manufacturing and regulatory requirements
- Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.
- Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
- Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.
- Ensures the quality assurance programs and policies are maintained and modified regularly.
- Act as Subject Matter Expert (SME) for the site in the areas of validation, calibration and manufacturing quality engineering support.
- Use quality engineering methods/techniques to ensure products released for distribution meet their intended performance requirements for safety and efficacy.
- Participate and provide technical support on technical project teams.
- Support manufacturing transfer from R&D.
- Support inter-site technology transfer.
- Prepares reports and/or necessary documentation and provides to applicable stakeholders, both internal and external.
- Work with Design QA with respect to compilation of risk assessments where applicable.
- Provision of trending and associated metrics for the areas of calibration, validation and manufacturing support.
- 3rd Level qualification (Level 8) in quality or a related discipline.
- Five or more years' experience in a quality role encompassing the areas listed above
- A good understanding ISO 13485, FDA QSRs, JPAL and Canadian Medical Device regulations is desirable for this position in tandem with strong analytical, technical writing and computer literacy skills
- Good working knowledge of Maths and statistics
- Familiarity with global regulatory standards associated with medical devices
- Excellent oral and written communication skills
- Lead auditor qualification preferred, not required.
Please call Tom Devaney today for further information on 091-758771 or email: firstname.lastname@example.org
CareerWise Recruitment (In Search of Excellence)