- BBBH814930 May 05, 2022 Competitive
If you are an experienced QM and are looking for an opportunity where you can over see multiple sites and products then this could be just the opportunity for you
This is a unique opportunity for an experienced Quality Manager to take the next step in their career. This position reports into the Director of Quality Assurance & Regulatory (based in the US) and is responsible for Quality Assurance activities associated with the Irish facility predominantly but will also have 2 US sites under their remit. Their permanent location will be in Limerick but a proportion of their week will also be spent managing the team in the US. In total across the 3 sites you are looking at a workforce of about 270 with about 10 people sitting in the Quality function. These sites produce millions of units and are heavily automated.
The successful individual will be responsible for compliance, certifications, complaints, corrective actions, and for the financial aspect of the quality function. 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 across all 3 sites.
DUTIES AND RESPONSIBIITIES:
- Customer-Facing Metrics (CFM) - Drive actions to improve performance to CFMs i.e On Time delivery, Complaint Response Time, Complaint PPM & Scrap management.
- Compliance/Certification - Maintain the FDA QSR / ISO 13485 - compliant Quality Management System, including assignment of primary contacts and coordinating training support. This individual will also manage the internal audit programme
- 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 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).
- Manage Department
- 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.
QUALIFICATIIONS & SKILLS REQUIRED:
- Bachelor's Degree in a related field across Science, Engineering or Quality
- Certification to internal auditing preferred.
- 5+ years Quality Management experience, with multi-site experience (with global cultural awareness), preferably in medical device, required.
- Strong P&L Leadership, financial acumen
- 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 use MS Office Tools such as Word, Excel, Project (or other project management software), Access and MiniTab® (or other statistics software).
- Ability to build respect/trust within internal staff/other functional leaders as well as external customers.
- Excellent interpersonal, communication (verbal and non-verbal), and presentation skills.
- Possesses excellent time management, prioritization abilities, and strong project management skills.
- Highly motivated, detail-oriented, and eager to drive needed change.
- Demonstrated ability to autonomously make strategic decisions.
- Ability to travel occasionally to other locations and for customer visits.
This is an extremely interesting and dynamic role. If you would like more information around this role and company then please click the 'apply now' button or contact Kellie O' Donovan on firstname.lastname@example.org or 021 2300 300.
A highly competitive package is on offer for the successful candidate.
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.
Principal Consultant | Engineering Recruitment - Quality & Validation
353 (0) 21 2300300