PMS QA Director

     

JOB DESCRIPTION:

QA Director – Post Market Surveillance, International Quality Operations

RMDx Infectious Disease,  Galway

Main responsibilities:

• Global role responsible for post market surveillance activities including complaint and recall management processes and post market surveillance performance reporting in compliance with company QS directives, IVDR and country specific regulations.
• Leads process improvements, metric tracking, and risk mitigation activities for assigned area.
• Directs a team who work closely with other functions (Call Registration, Medical Affairs Technical, Manufacturing etc) for assigned products under the RMDx Infectious Disease portfolio to assure on-going compliance with respect to post market surveillance.
• Collaborates with cross-functional team members to collect, analyze, trend and report on complaint data to proactively identify potential adverse safety risks or performance trends.
• Directs the development and implementation of methodologies required for ongoing area management.
• Escalates issues related to complaint trends, nonconforming product, etc, supporting CAPAs related to complaints.
• Proactively investigate, identify, and lead implementation of best in class quality practices.
• This individual is responsible for ensuring appropriate metrics/Key Performance Indicators are defined, measured and analyzed for continuous timeliness and improvement opportunities, with subsequent action taken as appropriate.
• Develops long range resource plans and hire resources according to plans. 
• The incumbent ensures compliance with applicable regulations, standards and company policies/procedures.

Qualifications:

• Bachelor's Degree preferably in a technical/scientific discipline e.g., Chemical, Physical or Biological Sciences, Pharmacy, Microbiology, Medical Technology, Engineering.   A minimum of eight years’ experience in a Quality or Technical area, including five years of direct supervisory experience. Experience should include quality, technical product support and /or development, budgetary responsibility, and functioning in a matrix-managed environment.
• Experience in the Medical Device and/or other regulated industry (Pharma, IVD).
• Strong knowledge of QSR, 21 CFR part 803, 820, ISO13485, Med Dev, ISO9001, EU MDR, etc.
• Excellent computer skills and previous application of Microsoft Excel, Word,
• PowerPoint, Project, Visio, database management, statistical analysis and reporting packages.
• Ability to acquire, query and analyze data with focus on detail.
• Excellent written and verbal communication, presentation, problem solving, applied thinking and negotiation skills.
• Leader with ability to successfully interact with representatives from a variety of subject areas.

Job Description Summary

• Global role overseeing post market surveillance activities for assigned RMDx Infectious Disease product portfolio.
• Identifies and implements appropriate quality systems to support an effective post market surveillance process.
• Works with other function (Call Registration, Medical Affairs, Regulatory, Technical etc) to support rapid handling of post market surveillance activities and ensure any confirmed deficiencies are managed appropriately with needed elevations.
• Assist in developing an engaged team with expertise and skill sets to advance ‘Quality First’ culture.
• Support audits from quality related regulatory agencies and notified bodies.
• Provides direction and coordination of quality activities utilizing continuous quality improvement principles and methodologies.
• Manage performance, training and development of staff.
• Prepare and manage annual budgets in areas of responsibility.

     

The base pay for this position is

N/A

In specific locations, the pay range may vary from the range posted.

     

JOB FAMILY:

Operations Quality

     

DIVISION:

ID Infectious Disease

        

LOCATION:

Ireland > Galway : Parkmore East Business Park

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Ie - 37.5Hst0 (Ireland)

     

TRAVEL:

Not specified

     

MEDICAL SURVEILLANCE:

Not Applicable

     

SIGNIFICANT WORK ACTIVITIES:

Not Applicable