- Reference: LK44408
- Job Type: Permanent
- Location: Clare, Limerick, Tipperary
- Category: Engineering, Technical & Manufacturing
- Be responsible for the strategic planning and management of ONV supplier compliance activities with management responsibilities over multiple sites.
- To develop, establish and maintain supplier quality business processes, engineering methodologies, and practices which meet, customer, and regulatory requirements.
- To serve as a Quality representative to improve awareness, visibility, and communication on quality initiatives supporting departmental, functional, site, divisional and corporate quality goals and priorities.
- Act as the key interface with site operations as it pertains to Supplier Quality Issues.
- Demonstrate a primary commitment to patient safety, product quality and compliance with the Stryker Quality Manual and its governing regulations.
- Investigate, identify, and implement best-in-class Quality Engineering practices across the ONV Supplier Quality.
- Provide technical guidance mentoring for identifying and resolving quality issues.
- Identify and communicate to ONV Quality leadership issues that impact product quality, safety or efficacy, regulatory compliance or business continuity which have arisen from a supplier.
- Identify and continually improve effective processes and systems to support IQA and Supplier Quality.
- Project management and leadership in the implementation of new requirements (regulatory, corporate and local) for the quality systems managed.
- Responsible for ensuring key site representation at external regulatory body audits – SME SQ.
- Ownership of key performance metrics and monitoring for areas managed
- Provide RHQ Quality and Operations Management with periodical supplier quality performance assessment and KPI’s of each Supplier
- Provide SME input to enable risk to be assessed and as an input to the quality planning process.
- Work closely with the SQM Partners in order to continuously improve the product quality, delivery and systems at the supplier base.
- Create a highly effective and motivated supplier quality compliance group across multiple locations while mentoring and coaching the team in leading best practices in supplier quality.
- Ensure employee engagement and satisfaction through active management of the teams, including but not limited to Q12 impact planning, one on one’s, IDP’s and 9 box reviews of all direct reports.
- Develop, plan, approve, manage and continually assess the supplier quality compliance activities and its tactical execution by the Supplier quality compliance teams.
- Ensure continuous quality compliance through quality improvement program for the Stryker supplier base.
- Leverage greater efficiencies in the supplier compliance group by developing and applying standardised/harmonised methodologies to the quality activity management and ensure tactical execution at the manufacturing sites.
- Drive effective closure of NC’s and CAPA’s, by mentoring and coaching NC/CAPA owners to ensure comprehension, development, and execution of corrective/preventive action with regards to any nonconformity cited.
- Ensure the supplier compliance program adapts to changes to both internal and external quality requirements.
- Conduct and support quality benchmarking activities.
- Identify areas of opportunity and support continual improvement of ONV Quality and work with the relevant groups on how these can be improved.
- Collaborate with the co-ordination of external body audit activities at the manufacturing sites as pertains to supplier interaction.
- Create and foster a strong working relationship with the different Global Supplier Quality functions, Global Quality, Strategic Sourcing and additional key interfaces to facilitate effective collaboration.
- Actively develop the team’s expertise and team dynamics through continuous coaching, promoting development programmes and formal appraisals through the performance review process.
- Bachelor’s degree in Science, Engineering or related subject. Advanced degree preferred. 8+ years relevant quality experience in GMP manufacturing environment in Medical Device, Pharma, Automotive or Aerospace industry.
- Thorough knowledge of current regulations, pertinent regulatory guidance and industry trends.
- An understanding of the technical aspects of the areas – understand the process, operational terminology etc.
- Experience in quality management systems is essential.
- Must possess strong communication, project management and leadership skills as well as have the ability to manage multiple projects simultaneously.
- Strong interpersonal skills.
- Strong leadership skills.
- Strong written and oral communication and negotiations skills.
- Highly developed problem solving skills.
- Strong analytical skills.
- Demonstrated ability to successfully manage and complete projects in a matrix organization.
- Demonstrated ability to lead cross-functional teams.
- Demonstrated ability to work independently.
- Demonstrated knowledge of U.S. Food and Drug regulations, as well as of European and international regulatory/industry guidelines/standards, and ability to interpret and apply.
- Computer literacy.
- Travel required 40-50%.
For a confidential discussion on the above role please contact Michael O’Leary on 061-512270
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