Our client, Boston Scientific in Galway are currently looking to recruit a Principal Quality Engineer
Senior Subject Matter expert within the Galway CIS group focused on the execution of insightful complaint investigation to meet requirement of the regulations, BSC Quality Management System, requirements of Post Market Quality Assurance and established annual objectives.
Develops, establishes and maintains quality engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements. Act as a SME on the Complaints investigation process. Serves as a Quality representative to improve awareness, visibility, and communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities. Provides focused quality engineering support within new product development, operational, or system/services support.
- Exercises a high degree of technical autonomy through developing robust and comprehensive processes for investigation of complaints, which complies with all current medical device standards such as 21 CFR Part 820, ISO 13485, MDD and MDR.
- Identifies program problems and obtains solutions, such as allocation of resources or changing scope specifications.
- Develops solutions to diverse business problems of high complexity which require the regular use of ingenuity and creativity. Analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. Has specialized knowledge of various alternatives and their impact on the business. Challenges are frequently unique and solutions may serve as precedent for future decisions.
- Leads system improvement teams using a variety of different methodologies and selecting appropriate techniques for problem solving and process improvements.
- Works without appreciable direction on highly specialized projects with long range quality objectives. Exercises considerable latitude in determining objectives of assignments. Selects methods and techniques to lead a project to completion. Develops departmental policies and procedures, new techniques and standards. Works with partners within Post Market Quality Assurance and across BSC organisation to reach goals.
- Has overall responsibility for generating project deliverables and timeline with specific milestone inputs from the responsible individuals within the team. Plans and organizes project assignments of substantial variety and complexity. Initiates or maintains schedule for projects milestones and shares/elevates to stakeholders and leadership team, as appropriate.
- Interfaces with senior management on significant matters, often requiring the coordination of activity across organizational units. May lead specialized project teams which have a broad impact on the company utilizing cross-functional resources.
- Serves as a consultant to management and special external spokesperson for the organization on major matters pertaining to its policies, projects, or objectives. Uses diplomacy and tact to diffuse high tension situations, particularly with senior level internal and external contacts. Occasionally escalates the most serious issues to manager.
- Develops and maintains collaborative relationships within the Galway site, the Post Market Quality Assurance organisation and acquisition sites, as well as sustaining strong partnerships with Quality Operations, Design Assurance R&D and Supplier Quality for the execution of insightful investigations and to support product performance improvements.
- Directs the work of employees assigned to the program/project and participates in the development of others by facilitating training and providing feedback and guidance.
Qualifications and Experience:
- HETAC Level 8 qualification in a STEM subject with a min. of 8-10 years’ relevant work experience.
- Demonstration of high proficiency in problem solving/ process improvement and project management skill sets and application.
- Knowledge on product design, manufacture, functionality and/or clinical use environment. Experience of Structural Heart product design or manufacturing and/or Angiographic image review experience would be an advantage.
- Experience of laboratory controls, equipment sourcing, and validation would be an advantage.
- Good technical capabilities, communication skills and organisation skills
- Demonstration of taking initiative to drive improvement and change.
- Proven ability to work well with teams but also to work with minimum supervision.
- Hepatitis B Vaccinations course required to work with returned decontaminated product.
- Ability to travel occasionally internationally for applicable assignment or meetings.
For further information on this Principal Quality Engineer in Galway please contact Orla Crowley Healy on 086 0449473 / email@example.com
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