Design Assurance Engineer
Purpose:
You will fulfill the quality assurance responsibilities of the
company**Apply on the website**;s new product development and post
market (commercial product) support, including:
? Demonstrating and promoting a commitment to improving patient
safety, customer satisfaction and product quality.
? Understanding and complying to quality, business, health & safety
systems and market/legal regulations governing the quality systems.
? Removing or mitigating against risks associated with the design,
use and manufacture of devices.
? Ensuring commitment to training requirements and understanding and
complying with all regulations governing your work.
Key Responsibilities:
General
? You will complete work assignments under limited
supervision/guidance.
? Interface with R&D, Regulatory Affairs, Clinical, Medical Safety,
Complaints Management Centres and Post Market Quality Assurance team
environment providing technical and quality systems input.
? You will be familiar with requirements and procedures that govern
medical device Design Control, Risk Management and Post Market
Surveillance.
? Identify and resolve complex exceptions to work assignments.
? Seek to support improvements in product and process quality.
? Build Quality into all aspects of work by maintaining compliance to
all quality requirements.
? Posess excellent interpersonal and communication skills with good
leadership abilities.
Technical
? Provides both quality and technical input to ongoing product
development and post market commercial product activities.
? Experienced in post market (complaints) support, risk management,
design and process change, standards compliance (to regulatory
requirements).
? Provides design quality support in the resolution of PIRs,
complaints investigation, CAPAs, VIPs, regulatory requirement changes.
? Excellent analytical and problem solving abilities. Analyses, draws
conclusions and makes appropriate decisions from risk management
activities and test data.
Leadership
? Is an active team member completing quality deliverables associated
with new product development and post market (commercial product)
support.
? Coaches others in areas of expertise. Gives technical guidance to
junior team members. Uses opportunities in project assignments to
develop self & others.
? Is a fully motivated team member - achieves and demonstrates best
practices in line with set objectives.
? Is willing to implement changes within the project/department
practices and supports a culture of challenging the status quo to
create best in class.
Qualifications & Experience:
? Level 8 (**Apply on the website** credits) in a STEM discipline
with a minimum of **Apply on the website** years**Apply on the
website**; experience in a similar role.
? Good technical capabilities, communication skills, teamwork
abilities and initiative.
? Proven ability to work well as part of a team & on own with minimum
supervision
For further information on this Design Assurance role in Galway please
contact Amanda Reynolds on (phone number removed)/
Check out all our open jobs on our HERO Recruitment website -
https(url removed)
Please Note: Under its obligation under the Data Protection
legislation, HERO Recruitment will not forward your details to any
company without your prior approval Location: Not Specified
Design Assurance Engineer
Purpose:
You will fulfill the quality assurance responsibilities of the
company**Apply on the website**;s new product development and post
market (commercial product) support, including:
? Demonstrating and promoting a commitment to improving patient
safety, customer satisfaction and product quality.
? Understanding and complying to quality, business, health & safety
systems and market/legal regulations governing the quality systems.
? Removing or mitigating against risks associated with the design,
use and manufacture of devices.
? Ensuring commitment to training requirements and understanding and
complying with all regulations governing your work.
Key Responsibilities:
General
? You will complete work assignments under limited
supervision/guidance.
? Interface with R&D, Regulatory Affairs, Clinical, Medical Safety,
Complaints Management Centres and Post Market Quality Assurance team
environment providing technical and quality systems input.
? You will be familiar with requirements and procedures that govern
medical device Design Control, Risk Management and Post Market
Surveillance.
? Identify and resolve complex exceptions to work assignments.
? Seek to support improvements in product and process quality.
? Build Quality into all aspects of work by maintaining compliance to
all quality requirements.
? Posess excellent interpersonal and communication skills with good
leadership abilities.
Technical
? Provides both quality and technical input to ongoing product
development and post market commercial product activities.
? Experienced in post market (complaints) support, risk management,
design and process change, standards compliance (to regulatory
requirements).
? Provides design quality support in the resolution of PIRs,
complaints investigation, CAPAs, VIPs, regulatory requirement changes.
? Excellent analytical and problem solving abilities. Analyses, draws
conclusions and makes appropriate decisions from risk management
activities and test data.
Leadership
? Is an active team member completing quality deliverables associated
with new product development and post market (commercial product)
support.
? Coaches others in areas of expertise. Gives technical guidance to
junior team members. Uses opportunities in project assignments to
develop self & others.
? Is a fully motivated team member - achieves and demonstrates best
practices in line with set objectives.
? Is willing to implement changes within the project/department
practices and supports a culture of challenging the status quo to
create best in class.
Qualifications & Experience:
? Level 8 (**Apply on the website** credits) in a STEM discipline
with a minimum of **Apply on the website** years**Apply on the
website**; experience in a similar role.
? Good technical capabilities, communication skills, teamwork
abilities and initiative.
? Proven ability to work well as part of a team & on own with minimum
supervision
For further information on this Design Assurance role in Galway please
contact Amanda Reynolds on (phone number removed)/
Check out all our open jobs on our HERO Recruitment website -
https(url removed)
Please Note: Under its obligation under the Data Protection
legislation, HERO Recruitment will not forward your details to any
company without your prior approval
We need : English (Good)
Type: Permanent
Payment:
Category: Others