Quality Assurance Manager

Glutalor Medical Inc
Exton, PA
Jul 31, 2017
Jobs Outside Higher Education
Other Jobs Outside Higher Education
Institution Type
Outside Academe

Job Description

Responsible for setting up the quality assurance system for manufacturing medical devices. The manger will lead the team to get facility certified for ISO13485/ISO14971 compliance, and meet requirement of CE/ FDA for device manufacture.

Detailed Responsibilities:
  1. Help to build, and administer the QA organization
  2. Develop QA procedures and standards to support manufacture of medical devices
  3. Lead efforts in bring the QA system compliant with European and FDA requirement for medical device manufacture
  4. Assist in draft and review quality documents for regulatory submission, and preparation for regulatory inspections.

  1. BS degree with a minimal of 6 years experience in medical device industry
  2. Thorough knowledge of FDA and European quality system requirements including GMP, ISO13485, 14971, Medical Device Directive and applicable quality system standards.
  3. Ability to analyze and interpret standards, technical procedures, professional journals, government guidance, and regulatory documents.
  4. Excellent verbal and written communication skills
  5. Proficiency with MS Office applications
  6. Demonstrated project management skills and experience

Company Description
A medical device manufacturer with product ready for launch.

Exton, PA


Sat, 15 Jul 2017 13:00:54 PDT