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Vacancy Details

Engineering & Technical

Senior Design Assurance Engineer - Galway

Contract Type: Permanent
Sector:
Location: Galway
Date: 26/10/2018
Job Reference: 100001
Contact Name: Bimi Felix
Contact Email: bimi@hero.ie

Job Description

Contact: Bimi Felix
Email: recruit@hero.ie
Telephone: 086 8395533

Senior Design Assurance Engineer
Our client, a medical device company in Galway is currently looking to recruit a Senior Design Assurance Engineer for their site.

Job Purpose
To provide QA technical and compliance expertise as part of teams tasked with establishing customer needs, developing new products and/or modifying existing designs. Assure compliance to applicable regulations and lead quality activities such as risk assessments, device testing, audits, procedure development, documentation review and changes to controlled documents. Provides design control, risk management and compliance support for product design and manufacturing, corrective and preventive actions, product/process improvements and complaint investigations.

Key Responsibilities
• Responsible for compliance of product development, risk management and post market activities with Policies and Procedures and applicable International Regulations.
• Works as part of product development team in identifying and translating user requirements into design requirements, identifying critical design features and components, including contributing towards the generation of risk management documents and associated reports.
• Complete design verification, design validation and test method validation activities associated with product development and implementing design/process changes.
• Works with R&D and manufacturing engineering in translating design requirements into manufacturing requirements, including the development of manufacturing test methods and implementation of production monitoring and controls.
• Leads the resolution of project issues by working with team members, suppliers, and others as appropriate. Apply thorough, systematic problem-solving methodologies in identifying, prioritising, communicating, and resolving quality issues.
• Monitors compliance with Company policies, procedures and applicable regulatory requirements, identifying, reporting and implementing process and system improvements.
• Demonstrate an ability to apply, recommend and/or create quality tools and apply them effectively to a variety of business situations related to product development, post market activities, project and team environments.
• Represent the company professionally and positively to external agencies, vendors and regulators.

Other responsibilities will include
• Leads and/or facilitates compliance and improvement activities associated with the quality system (e.g. CAPA, audit programs, personnel training).
• Actively participates in and supports departmental activities and responsibilities in accordance with existing procedures and external regulations.
• Plan, execute, report and follow-up on quality system audits. Act as an audit escort and/or support in the coordination of backroom activity during inspections as required.
• Makes decisions that are aligned with management objectives regarding work processes, plans and schedules in order to achieve quality objectives.
• Tracks and reports progress across projects and departmental commitments by reviewing schedules and due dates, identifying risks, and assisting teams with contingency plans. Assists department and project leaders in developing and reporting appropriate performance and quality metrics.
• Reviews and approves operational, test and validation data to establish conformance to technical specifications and performance standards for existing, new or modified products and processes.
• Provides technical quality guidance to team members, technician and inspection staff.
This is primarily an office based role, but assignments may require placement in a production/cleanroom environment. The successful candidate must be able to travel (national and international) – approx. 5-10% of role.

Essential Skills / Experience
• Minimum Bachelor's Degree in Engineering, Science or related technical field.
• 6 years minimum QA, Quality System or regulatory experience in the medical industry a prerequisite. Ideally includes a minimum of 4 years in the QA activities associated with a product development including project management skills and leadership ability.
• Knowledge of FDA’s 21 CFR Part 820 (Quality System Regulation), ISO 13485:2016, the European Medical Device Regulations, the Canadian Medical Device Regulations and other international standards and regulations.
• Results and deadline driven with an ability to handle multiple tasks and operate in a fast-paced environment.
• Excellent interpersonal skills and ability to work with people to achieve results.
• Excellent written and communication skills, fluency in English. Proficiency in MS office products.
• Experience in preparation for notified body and FDA inspections.
• Good judgment/decision making and problem-solving ability, capable of understanding the impact of decision making on the company and their customers.
• Highly motivated and an enthusiastic self-starter with the ability to work under own initiative and as a team player.
• Good business acumen.

Key Relationships/ Interfaces
Regulatory, R&D, Clinical, Marketing, Operations, Distribution, External Services Suppliers

Behaviours/ Values
• Approachable and enthusiastic.
• Strong attention to detail
• Flexible and adaptable.
• Able to work on own initiative and as a team player.
• Good organizational skills with cultural awareness and sensitivity
• Demonstrates and actively promotes the highest levels of professional behaviour and personal integrity


For further information on this Senior Design Assurance Engineer role in Galway please contact Bimi on 086 8395533 / recruit@hero.ie

Check out all our open jobs on our HERO Recruitment website – www.hero.ie
Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.

Clients we are proud to work with

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“I have worked with HERO recruitment (formerly HERO recruitment) for a number of years both within my current and previous position. I have always found HERO recruitment excellent to partner with, the consultants know our industry and cultural fit and can therefore successfully source high calibre candidates to match our open vacancies. I find HERO recruitment very professional to deal with and any candidates I interview who are sourced by HERO always have a positive recruitment experience”.

Moira Faherty,
Human Resources Manager
Chanelle Group

“My very first impression was that I was dealing with a recruitment company who were extremely professional, supportive and knowledgeable of the role for which I was applying. Not only were the responsibilities of the role explained to me in great detail, but they also went to great lengths to really understand the depth of my technical, managerial and leadership experience and capabilities. What impressed me the most was their personal touch in building a strong relationship with me as a candidate and in maintaining regular contact with me on the status of the role throughout the application process”.

Adrian Rice,
Engineering Manager 
Boston Scientific

“HERO have been a key strategic recruiting partner to Hollister ULC over many years. During our continued growth and expansion at our facility in Ballina, Hero have worked closely with us to really understand our recruiting needs, the calibre of talent we are looking for, and the fit for our Hollister culture. HERO have successfully sourced and placed candidates for us into Research and Development, Project / Process Engineering, Supply Chain and key Management roles.  They have a very experienced and professional team, and bring an excellent regional, national and international perspective”. 

Tom Horkan,
Asst. HR Manger
Hollister ULC, Ballina, Co. Mayo

"From the first prompt call-back to the ultimate congratulatory call to inform me of a job offer, Karl was an absolute professional; sound advice, solid research and knowledge of companies, unwavering persistence and friendly encouragement. West is best, so for anyone looking for a technical role, talk to Karl"

Fiachra Collins
Computer Vision Algorithm Team Manager
Valeo

“HERO Recruitment continues to be a valued partner in supplying high calibre candidates to all three Boston Scientific sites in Ireland. In particular they have been successful in delivering on specific roles for key project scale-ups. HERO has also provided on-site recruitment presence during increased activity when required and consistently operate in a highly professional and competent manner”.   

Lorraine McDonnell,
Senior Talent Acquisition Specialist
Boston Scientific 

“HERO Recruitment were instrumental in sourcing and delivering key talent to the organisation and enabled us to meet our key deliverables within our start-up phase. They thoroughly understood our culture and constantly over delivered on our expectations. Our partnership with HERO Recruitment has without a doubt been  a professional and collaborative one. HERO exceed themselves in all aspects of recruitment and are an absolute pleasure to work with”.

Christine Power,
VP of Human Resources
Pivot

“HERO recruitment is an extension to our talent acquisition team. From hiring strategy meeting to the induction of the right talent, the HERO recruitment team provide an exemplary service. They are knowledgeable about our business needs, responsive and thorough. A true talent acquisition partner”. 


Orla Keady-Giblin,
Human Resources Manager
Ingersoll Rand – Thermo King
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“I have worked with HERO recruitment (formerly HERO recruitment) for a number of years both within my current and previous position. I have always found HERO recruitment excellent to partner with, the consultants know our industry and cultural fit and can therefore successfully source high calibre candidates to match our open vacancies. I find HERO recruitment very professional to deal with and any candidates I interview who are sourced by HERO always have a positive recruitment experience”.

Moira Faherty,
Human Resources Manager
Chanelle Group

“My very first impression was that I was dealing with a recruitment company who were extremely professional, supportive and knowledgeable of the role for which I was applying. Not only were the responsibilities of the role explained to me in great detail, but they also went to great lengths to really understand the depth of my technical, managerial and leadership experience and capabilities. What impressed me the most was their personal touch in building a strong relationship with me as a candidate and in maintaining regular contact with me on the status of the role throughout the application process”.

Adrian Rice,
Engineering Manager 
Boston Scientific

“HERO have been a key strategic recruiting partner to Hollister ULC over many years. During our continued growth and expansion at our facility in Ballina, Hero have worked closely with us to really understand our recruiting needs, the calibre of talent we are looking for, and the fit for our Hollister culture. HERO have successfully sourced and placed candidates for us into Research and Development, Project / Process Engineering, Supply Chain and key Management roles.  They have a very experienced and professional team, and bring an excellent regional, national and international perspective”. 

Tom Horkan,
Asst. HR Manger
Hollister ULC, Ballina, Co. Mayo

"From the first prompt call-back to the ultimate congratulatory call to inform me of a job offer, Karl was an absolute professional; sound advice, solid research and knowledge of companies, unwavering persistence and friendly encouragement. West is best, so for anyone looking for a technical role, talk to Karl"

Fiachra Collins
Computer Vision Algorithm Team Manager
Valeo

“HERO Recruitment continues to be a valued partner in supplying high calibre candidates to all three Boston Scientific sites in Ireland. In particular they have been successful in delivering on specific roles for key project scale-ups. HERO has also provided on-site recruitment presence during increased activity when required and consistently operate in a highly professional and competent manner”.   

Lorraine McDonnell,
Senior Talent Acquisition Specialist
Boston Scientific 

“HERO Recruitment were instrumental in sourcing and delivering key talent to the organisation and enabled us to meet our key deliverables within our start-up phase. They thoroughly understood our culture and constantly over delivered on our expectations. Our partnership with HERO Recruitment has without a doubt been  a professional and collaborative one. HERO exceed themselves in all aspects of recruitment and are an absolute pleasure to work with”.

Christine Power,
VP of Human Resources
Pivot

“HERO recruitment is an extension to our talent acquisition team. From hiring strategy meeting to the induction of the right talent, the HERO recruitment team provide an exemplary service. They are knowledgeable about our business needs, responsive and thorough. A true talent acquisition partner”. 


Orla Keady-Giblin,
Human Resources Manager
Ingersoll Rand – Thermo King
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Clients we are proud to work with

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