New Job! Quality Assurance and Regulatory Affairs
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New Job! Quality Assurance and Regulatory Affairs

Quality Assurance & Regulatory Affairs Manager

Full Time, Permanent
Tauranga, Bay of Plenty
New Zealand
 
Or client is looking for a Quality Assurance and Regulatory Affairs Manager to work with a talented group of Senior Managers, business leaders and quality personnel to ensure quality and compliance remain a priority to continue growing this fast moving company.

The QA & RA Manager is responsible for implementation, management and sustainment of the Division-wide quality assurance program to ensure conformity with US FDA, EU, ISO, CMDCAS, JPAL and other applicable quality and regulatory requirements. As such this role requires a strong manager with demonstrated execution skills, and a record of success in managing and leading an overall quality system and driving successful continuous improvement efforts.

The role includes developing, implementing and maintaining corporate quality standards, policies, procedures, and processes; ensuring that all applicable regulatory filings are made and approvals are obtained prior to product beings shipped from the division, interfacing with external regulatory bodies, facilitating external inspections or audits and providing regular and timely updates to the Managing Director as to the compliance status of the Quality System.

The successful candidate will have proven leadership skills, problem solving expertise, sound risk management decision-making and excellent management skills in identifying and implementing continuous quality system improvements. They are empowered and accountable to ensure that all finished products conform to specified requirements, and that finished products which do not conform to requirements are prevented from being used or delivered

Ideally we are looking for a Quality Assurance & Regulatory Affairs Manager with:

  • Bachelor's degree in Science / Engineering / related technical field, CQE and/or Six Sigma Certification
  • 5-10 years experience in Regulatory and QA in a related regulated medical device or pharmaceutical environment is required
  • Experience managing a team of 5 or more direct reports
  • Previous experience in developing, implementing and embedding Quality Systems in GMP regulated manufacturing environments working with ISO, GMP, FDA or other key regulatory bodies
  • An in-depth understanding of 21CFR820 and ISO13485
  • Great project management skills  
  • Training experience and the ability to assess and monitor learning outcomes
  • Validation and Testing experience (ability to write, approve and perform test protocols, DOE, Gage R&R, ANOVA, SPC, Pareto Analysis)
  • Demonstrated knowledge of Quality Management Systems and experience linking risk management to all elements of the Quality System (Design Controls, CAPA, Complaints, Document Control etc)
  • Design control experience (review/approve DMRs, Technical Files and DHFs)
  • Highly proficient computer skills, MS Office and Minitab (an advantage)
  • Sound statistical knowledge and excellent reporting skills at senior management level
  • Internal auditing ISO13485 QMS experience (3+ years)
  • Exceptional written and oral communication skills.
 
Please APPLY ONLINE HEREwith your CV and Cover Letter to One21 The Recruitment Outsourcer
Or for a confidential enquiry you can contact:

Kirsty Morrison @ One21 Recruitment
Specialists in Medical Device Manufacturing Roles
Ph: 021 355 179
Email Kirsty.recruiting@gmail.com
www.therecruitmentoutsourcer.com
 
One21 - for 'out of the box' Recruiting Solutions
 

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