This position reports to Director, Quality Assurance & Regulatory and is responsible for Quality Assurance activities associated within Ireland and 2 sites in the US. The individual will be responsible for compliance/certifications, complaints/corrective actions, and for the financial aspect of the quality function specifically tied to ownership of scrap and non-value-add activity reduction. This individual will champion the use of the Quality System, convert data to information to drive continuous improvement, and manage a team of quality professionals and inspectors (to support their efforts, development, and growth).
DUTIES AND RESPONSIBIITIES:
- Customer-Facing Metrics (CFM) – Drive actions to improve performance to CFMs
- On-Time Delivery – Ensure management of processes to help improve compliance to customer requested delivery dates and investigation of late deliveries to promote improvement.
- Complaint Response Time – Works with Quality Team, Peers, and other Team Members to ensure complaints are properly investigated, acted upon and responded to in a timely manner.
- Complaint PPM – Works with the Plant Management Team and other Team Members to reduce systematic contributors to defects and to ensure appropriate detection practices are implemented.
- Scrap – Drives improvement in and motivates team member engagement to identify effective solutions for scrap reduction.
- Maintain the FDA QSR / ISO 13485 – compliant Quality Management System, including assignment of primary contacts and coordinating training support.
- Ensure Management reviews are conducted to provide for systems review.
- Manage Internal Audit Program.
- New/Change Product/Process Validation
- Oversee management of Validation activities
- Ensure appropriate protocols are written, identified actions are completed, inclusive reports are written.
- Management of Implementation and Documentation of IQ, OQ, PQ
- Ensure timely and conclusive validations, including validation reports.
- Participate in Design Reviews, including Technical Reviews, Feasibility Discussion, and Failure Modes and Effects Analysis (FMEA).
- Assist in documenting development work including supporting writing specifications for manufacturing or identifying and/or evaluating scientific test results.
- Complaint/Corrective Action Management
- Act as direct contact (where appropriate) or manage contact (through Quality Engineers) for customer quality-related issues; coordinate course of action for alleviating and resolving concerns and providing timely responses.
- Identify corrective/preventive actions for continuous improvement (effectively implemented and closed in a timely manner) and quality improvement as needed for Production and Business Unit Goals.
- Ensure completion of necessary paperwork such as CAPACIAs, Alerts, and other relevant documents.
- Ensure Root Cause Analyses are conducted to establish reasons and solutions for Quality matters.
- Financial Management with Plant Management Teams and Reports for Process/Cost Control
- Maintain product supply with minimum Scrap and NVA activities.
- Drive Front-to-Back improvement by using data-based information to drive Scrap Reduction, elimination of NVA activities, and On-Time Delivery improvement to drive action needed for the QRTF (Quality & Regulatory Task Force).
- Use charts/graphs/data to lead/support scheduled meetings.
- Offer input for areas of improvement in products, processes, and procedures.
- Provides partnership with our First Teams to champion employee engagement efforts.
- Manages talent acquisition and develops new hire onboarding plans as needed.
- Provides frequent performance feedback and completes annual reviews for the team.
- Guides the Quality team to manage daily production activities with minimal direct supervision.
Candidate Requirements :
· Bachelor’s Degree in Science, Engineering, Business or related field required, certification to internal auditing preferred.
· 5-7 years Quality Management experience, with multi-site experience (with global cultural awareness), preferably in medical device, required.
· Strong Leadership skills
· Experience driving zero PPM in a lean manufacturing environment. Knowledge/experience with ISO 13485 and 21 CFR 820, or equivalent, quality system requirements required.
· Ability to travel occasionally to other sites (US) and for customer visits.
For a confidential discussion and more information on the role, please contact Rory Walsh.