Design Assurance Manager

HERO

Job Detail

Location Galway Galway
Salary Negotiable
Posted
Role Type Permanent
Contact Elaine Ferguson
email connect@hero.ie

Design Assurance Manager

Apply Now

Job ID: JOB-12737
Design Assurance Manager
Permanent position
Galway


Exciting new role for a Design Assurance Manager to join one of our leading medical devices clients in working in a global function based in Galway. This company stands out for their culture, exceptional career development pathways and unrivalled rewards and recognition packages. This new job opportunity is located Galway. Galway, voted “Europe’s most Friendliest City 2020”!

Apply to us to find out more about this great job opportunity in Galway and we can talk though if it’s the right job for you. Due to the continued expansion our client is seeking a suitably qualified and experienced Design Assurance Manager As Design Quality Assurance Manager, you will join the rapidly growing Interventional Cardiology – Coronary Therapies Franchise. You will provide design assurance leadership and strategic direction in this role by partnering with our global Coronary Therapies Valve R&D, Regulatory, Quality, Post Market, and Marketing teams. This will be an exciting journey! This is a unique opportunity to lead design assurance strategy and execution through the full development life cycle.

Responsibilities

  • Lead the Design Assurance for New Product Introduction, Sustaining Engineering for commercialized products, and Post Market Surveillance activities
  • Be the SME and lead in the areas of QSR and ISO/MDD standards, constantly promoting awareness of best industry practices and making appropriate decisions on a daily basis using the Design Assurance Director as the final arbitrator on critical quality decisions.
  • Ensure effective implementation of Risk Management deliverables to achieve compliance with ISO 14971 and demonstrate a primary commitment to patient safety.
  • Lead project teams and franchises in the execution of Quality Deliverables, including but not limited to Post-Market Surveillance Plan & Report, Field Assessment Plan and Clinical Evaluation Reports
  • Make decisions related to product quality, including the disposition of the non-conforming products.
  • Develop and manage a high-performance design quality assurance team focusing on customer needs, compliance, product quality, and risk mitigation.
  • Drive continuous improvement by championing and fostering the execution of projects within the local and Global Design Assurance and Post Market organizations to drive the process and product performance.
  • Participate with and present to appropriate Corporate Quality teams.
  • Develop, direct, and ensure appropriate execution of design planning, verification, validation, and useability requirements for newly designed or modified products and processes.
  • Take a leadership role in developing and implementing new techniques and initiatives to enhance the Quality management system on-site and across the Corporation where possible.
  • Develop staff on new quality initiatives and assist in understanding and rolling out quality initiatives across the department/site.
  • To establish and support a work environment of continuous improvement that supports the Quality Policy, Quality System and the appropriate regulations for the area.
  • Ensure employees are trained to do their work, and their training is documented.

Qualifications and Experience:

  • Bachelor’s Degree in Mechanical Engineering, Materials Science, Biomedical Engineering or other relevant technical disciplines.
  • 8-10 years of related work experience.
  • Proven technical leadership and project management skills in medical device design, development and commercial launch.
  • Proven experience in a leadership position as an Independent critical thinker, strong communicator, and networker.
  • Ability to interface with customers to gather insight and get organizational buy-in on key design inputs.
  • Knowledge/Experience of Design Controls and FDA/ISO Medical Device Regulations.
  • Understanding of risk management and design controls tools and requirements for medical device product development.
  • An influential team member, fully motivated to achieve and demonstrate best practices in line with the department and long-range planning objectives.
  • Familiar with the internal auditing process.

For further information on this role in please contact Elaine Ferguson at connect@hero.ie or 087 4108620

Check out all our open jobs on our HERO Recruitment website – https://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. Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review you data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.

Elaine Ferguson

JOB-12737

Apply Now

Design Assurance Manager

Elaine Ferguson

Role Type Permanent
Contact Elaine Ferguson
email connect@hero.ie
mobile +353 87 410 86 20
linkedIn profile click here

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