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Design Assurance Manager

  • Sector: Engineering
  • Contact Email: michelle.mcinerney@collinsmcnicholas.ie
  • Job Ref: 19036

Our client a Major Multi National here in Galway are looking to hire a Design Assurance Manager.


The Role:

In this role, you will provide design assurance leadership and strategic direction by partnering with R&D, Regulatory, Quality and Marketing teams. 

 

Responsibilities:

  • Areas of responsibility may include: Design Assurance for New Product Introduction; Sustaining Engineering for commercialized products; Post Market Surveillance activities
  • Is viewed as a leader or expert in the areas of QSR and ISO/MDD standards within ones own group, 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.
  • Ensures effective implementation of Risk Management deliverables to ensure compliance to ISO 14971 and demonstrates a primary commitment to patient safety. Leads 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
  • Has the responsibility and independent authority to make decisions related to product quality, including the disposition of non-conforming product.
  • Develops and manages a high performance design quality assurance team with focus on customer needs, compliance, product quality, and risk mitigation.
  • Drives continuous improvement by championing and fostering the execution of projects within the local and/or Global Design Assurance and Post Market organizations to continue to improve process and product performance. 
  • May be a member of and present to appropriate Corporate Quality teams.
  • Develops, directs and ensures appropriate execution of design planning, design verification, design validation and useability requirements for newly designed or modified products and processes.
  • Takes 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.
  • Is key to developing staff on new quality initiatives and assists understanding and rollout of quality initiatives across the department/site.
  • Is an influential team member, fully motivated to achieve and demonstrate best practices in line with the department and long range planning objectives.
  • Is familiar with the internal auditing process.
  • To establish and support a work environment of continuous improvement that supports the company Quality Policy, Quality System and the appropriate regulations for the area.
  • Ensure employees are trained to do their work and their training is documented. 

Requirements:

  • Bachelor's Technical Degree such as Mechanical Engineering, Materials Science and/or Biomedical Engineering.
  • 8-10 years of related work experience.
  • Proven technical leadership and project management skills in medical device design, development and commercial launch.  
  • Proven key leadership traits of ability to be independent critical thinker, strong communication skills and ability to build effective cross-functional relationships
  • 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.

For more information or a confidential discussion about this role please contact Michelle Mc Inerney.

michelle.mcinerney@collinsmcnicholas.ie

091 706 717