- Supervision and coordination of Product Quality Assurance activities with a focus on timeliness and process improvements, incl. but not limited to:
- Coordination and documentation of complaint evaluations, investigations, and approvals with Strong customer focus and using problem-solving skills
- Coordination and support of risk evaluations performed for potential Quality issues as well as subsequent field correction and vigilance activities
- Trending and tracking of complaint data and systematic evaluations.
- Support initiation of QPIs and Quality Communications.
- Providing and presenting Metric Data for Management Review and site scorecard
- Support of the global potential RE/MDR/MDI analysis process and respective updates.
- Coordination of PQA support for R&D projects, PDMRB and post-market review activities, product transfers, or other relevant projects.
- Team Leading and Personnel Management.
- Ensures operations are performed in accordance with applicable site and Division procedures with strong attention to detail.
- Continuous consideration of process improvements and implementation.
- Continuous consideration of priority and resource management, including cross-site support.
- Ensures training and development for assigned area.
- Implementation and maintenance of operating procedures relevant to assigned area.
- Input to an investigation-, ER/CAPA- and Change Control process.
- Identifies and flags potential quality issues and works co-operatively with required interfaces, other departments, and other Abbott sites.
- Works independently on projects and process improvements.
- Subject Matter Expert for assigned area-related processes.
- Support of Internal and External Audits.
- Act as the delegate for his/her/their Manager, if assigned.
- Beyond the general legal obligation to prevent accidents, PQA Supervisor is assigned certain duties in respect to environmental protection and work safety which ties in directly with her/his position within the company. It is his/her/their task to support actively Abbotts environmental goals, to keep the sequence of operations free of risks, and to ensure employees under her/his supervision follow the rules for safe behaviour at work.
- MSc or BSc in Engineering, Business, or related discipline, OR adequate work experience in the relevant industry such as MTA, BTA, CTA or equivalent qualification
- With MSc we will require more than 2 years of experience in IVD or similar industries
- With BSc we will require more than more than 4 years of experience in IVD or similar industries.
- With MTA, BTA, CTA or equivalent qualification more than 6 years of experience in IVD or similar industries.
- Previous people management experience is essential for this role.
- Good oral and written English
- Good leadership, communication and organization skills
- Proficient in Microsoft Office (Word, Excel & PowerPoint)
- Good software and report writing skills
For further information on this role in please contact Michael Marvin on 0864409255 or email firstname.lastname@example.org
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