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Quality Team Lead - Post Market

ID
14402
Location
Limerick, Ireland
Role Type
Permanent
Contact
Lisa Lawlor
Email
stem@hero.ie
Phone
+353 86 839 5533
LinkedIn
click here
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Quality Team Lead – Post Market

Feeling like work is lacking the challenge for you right now?  Is career development, a great team and good rewards important to you?

This Quality Team Lead – Post Market job opportunity located in Limerick could be just what you’re looking for. 

The primary function of this position is to manage a team of Engineers focused on design modifications of devices post release to market, for the purpose of maintaining device quality and compliance, securing regulatory approval, as well as reducing costs and increasing yields.

In this position you’ll report into the Manager of Post Market Engineering, leading a team focused on the delivery of CAPA or Design Projects.

Responsibilities: 

  • Provide leadership and mentoring to team members to ensure their development and the effective completion of the activities associated with their role. 
  • Team Management: 
    • Mentoring, coaching and development of direct reports to attain best performance. 
    • Perform routine appraisals to deliver best results and to obtain the maximum team performance. 
    • Manage the activities of the Post Market Engineering team and hold regular team meetings. 
    • Ensure KPI’s and business metrics are achieved. 
  • Ensure the Post Market Engineering team are in compliance with The Company's Quality System requirements and Company HR policies. 
  • Work with Manager, Post Market Engineering and other Snr. Engineers to ensure the appropriate allocation of resources and prioritisation of efforts for the overall Post Market Engineering group. 
  • Collaborate with other Post Market / Manufacturing Engineering Teams to ensure the effective completion of all activities associated with Post Market Engineering projects / objectives. 
  • Ensure effective reporting to the Manager, Post Market Engineering Manager. 
  • Work closely to build effective relationships with other functions in particular Production, Quality and Regulatory teams. 
  • Responsibility for approval of design history file documentation. 
  • Lead the delivery of CAPA or Design projects with responsibility for the following: 
    • The completion of the Investigation / Root Cause Analysis ensuring consistency in terms of methodology used and outcome achieved. 
    • The identification and implementation of appropriate corrective / preventative action, and collaboration with other functions to ensure same if they are impacted. 
    • The verification of effectiveness of CAPA’s. 
    • Ensuring that CAPA’s are completed on time, planned effectively and that plans are tracked and communicated effectively to relevant stakeholders. 
    • Where Engineering are not the CAPA assignee / process owner work closely with CAPA / Process owners to provide guidance on items above ensuring a consistent approach and outcome across all functions on site. 
  • Identify and guide team in the successful implementation of: 
    • Design changes that will improve existing device quality, performance and efficacy. 
    • Cost reduction and yield/efficiency improvement opportunities. 
  • Support Regulatory Affairs as required with engineering input for design related submissions and renewals post initial release of devices to market. 
  • Maintenance and remediation of Design History Files for existing devices to ensure compliance with relevant procedures, standards or guidance documents. 
  • Maintenance of the Risk management files for existing devices 
  • Support the post market surveillance of devices in terms of complaint investigation and risk analysis. 
  • Provide engineering support for post market clinical studies if required. 
  • Liaise with Research and Development teams to ensure the effective transfer of design history files for new devices from Research and Development to Post Market Engineering. 

  

Qualifications: 

  • Bachelor’s degree in engineering or related field required and 7 years’ relevant experience. 
  • Strong proven people management skills. Previous experience in a supervisory position desired. The ability to supervise, lead and motivate a group of talented engineering staff. 
  • Strong interpersonal skills and the ability to communicate at all levels of the organisation. 
  • Strong knowledge of medical device quality standards ISO13485/FDA practices and GMP or similar regulated industry standards. 
  • Proven problem-solving skills. 
  • Good computer skills including knowledge of Microsoft® Office. 
  • Excellent organisational and team building skills. 
  • High self-motivation. 
  • Willingness and availability to travel on company business. 

 

Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/

For More info on this role please contact Lisa Lawlor on 086 839 5533 or Stem@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.

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