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Quality Assurance Manager-Medical Device-GREAT OPPORTUNITY

Industry: Life Sciences

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Quality Assurance Manager-Medical Device-GREAT OPPORTUNITY

Our client, an emerging medical device technology company located in southern New England, is seeking a Quality Assurance Manager who would be responsible for assuring overall regulatory compliance with FDA Quality Systems Regulations, Medical Device Directives and ISO standards.

Job Responsibilities:

  • Establish and maintain company compliance to FDA QSR, ISO and related standards, regulations, and requirements.
  • Develop and/or manage quality programs. Internal and supplier audits, CAPA, complaints, etc…
  • Enforce compliance with quality system procedures and regulatory requirements through internal and external auditing and maintain evidentiary records by supporting procedure development, implementation, and reviews. 
  • Leads execution of validation activities for both new and inline products.
  • Participate in Design Reviews for key milestones by ensuring quality systems are in compliance with relevant US and foreign standards and codes.
  • Suggest methods for improving product quality, design, or manufacturing processes.
  • Supervise and mentor quality assurance personnel.

Job Requirements:

  • BS/MS degree in an applied or life science
  • Minimum of 5+ years experience in Quality Assurance environment with specific experience in aseptic compliance, validation, filing and creation of quality systems manual.
  • Working knowledge of clinical laboratory regulations and compliance standards required, including FDA and EMEA regulatory requirements. Knowledge of NSF certification a plus.

Location:

  • New York, NY
  • Boston, MA 

Compensation: $94,000. (Compensation commensurate with experience.and salary  history) Complete benefits package, annual target bonus and relocation available.

For confidential consideration, please forward your resume in a Word document to: bthornton@kleinhersh.com. Visit www.kleinhersh.com to view other job opportunities available through our company.

For additional information about this job, please contact: bthornton@kleinhersh.com