Accessibility Links

Quality Assurance Manager - Medical Device

  • Job type: Permanent
  • Location: Windsor
  • Salary: $90000 - $130000 per annum
  • Job reference: MERZ011118441
  • Sector: Quality Assurance, EPM Scientific, Quality
  • Date posted: 11/01/2018
QUALITY ASSURANCE MANAGER - MEDICAL DEVICE 
  • MEDICAL DEVICE COMPANY
  • Windsor, CT
  • $90,000 - $130,000 + Bonus + Benefits + Excellent Career Growth
The Quality Assurance Manager will provide leadership to include in-process quality assurance, quality inspection, document control, process monitoring, acceptance testing, validations, and final release activities. This role will overlook Quality Engineering, Quality Assurance, and Document Control to ensure compliance to all standards and regulations, in addition to customer requirements. The Quality Assurance Manager will improve and maintain the effectiveness of the QMS throughout an on-going basis. 

The Quality Assurance Manager will be have the following responsibilities:
  • Overlook all Quality activities
  • Implement and maintain ISO 13485, ISO 9001, FDA, GMP, as well as all Medical Device standards and regulations in QA, R&D and Manufacturing areas
  • Manage change control for quality system effectiveness
  • Develop and lead all process, equipment and product validations
  • Act as the main contact within Quality

The Quality Assurance Manager will have the following skills & experiences:
  • 3+ Years experience within a Quality Assurance managerial position in Medical Device Industry
  • BS Degree in Sciences (Biomedical Engineering, Chemical Engineering, Mechanical Engineering, or similar)
  • Strong working knowledge in relation to ISO 13485, ISO 9001, 21 CFR 820, 21 CFR 210/211 and FDA requirements
Similar jobs
Senior Medical Writer
  • Job type: Permanent
  • Location: Hitchin
  • Salary: Competitive
  • Description A dynamic and independent medical communications organisation, based in Hitchin, Hertfordshire are offering a Medical Writer the chance to take the next step in their...
Freelance Quality Consultant
  • Job type: Contract
  • Location: Oslo
  • Salary: Competitive
  • Description The Role: ***A Global biotech company is looking for 2x Freelance Quality Consultant to work on a 6- 12 Month project based in Norway to...
Sr QA Manager External Supply/CMO - Europe
  • Job type: Permanent
  • Location: Amsterdam
  • Salary: Competitive
  • Description Sr QA Manager External Supply/CMO - Europe The Netherlands - Amsterdam My client has recently acquired a new CMO division to add to their vast product portfolio....
Senior Pharmacovigilance Physician
  • Job type: Contract
  • Location: Basel
  • Salary: Competitive
  • Description An international medium-sized biotechnology and pharmaceutical company is searching for an experienced Drug Safety Physician to join an experienced team of consultants. The company is...
Area Sales Manager – Genetics
  • Job type: Permanent
  • Location: Dortmund
  • Salary: Competitive
  • Description Area Sales Manager North Germany – Genetics A leading Life Sciences company is seeking an experienced Sales Representative DNA/RNA purification and extraction reagents for