Randstad Quality Assurance Manager in Brooklyn, New York

Quality Assurance Manager

job details:

  • location:Brooklyn, NY

  • salary:$100,000 - $130,000 per year

  • date posted:Wednesday, March 14, 2018

  • job type:Permanent

  • reference:425506

  • questions:212-213-3600.

job description

Quality Assurance Manager needed for Medical Device Company in DUMBO Brooklyn:

Quality Assurance Manager

Job Description:

The Quality Assurance Manager will be responsible for the management and improvement of the Quality Management System and day-to-day management of QMS processes and regulatory compliance.

Responsibilities will include:

  • Lead continuous improvement of the QMS and other department processes, including reviewing, updating, creating, and implementing SOP's to support improved processes and compliance

  • Maintain the Quality Management System and its processes to meet FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements

  • Act as the management Representative for FDA and third-party audits

  • Prepare and monitor quality plans and metrics to support operations

  • Manage the complaint handling process including documenting, investigation, and reporting

  • Manage a Quality Control team of up to 4 direct reports focusing on effectiveness of QC operations, continuous improvement, and employee professional development

  • Training of new employees on GMPs and Quality procedures, and ongoing training for current employees

  • Collaborate with cross functional groups during new product development to ensure design controls, risk management, verification and validation, and product transfer

  • Manage Document Control, along with change control, CAPA, and NCMR processes related to the QMS, production, complaints, contract manufacturer performance, and material suppliers

  • Lead the supplier qualification program

  • Preparation of 510(k) submissions for new products

  • Responsible for annual FDA Registration and new device listings

  • Management of all quality records

Experience and Qualifications:

  • Experience in medical device manufacturing is a MUST

  • Bachelor's degree from an accredited college, preferably in an Engineering or Science field

  • 3+ years' experience with FDA 21 CFR 820, medical device quality management systems

  • Knowledge of general quality principles, FDA Regulations, EU Medical Device Regulations, Health Canada Regulations, ISO 13485, ISO 14971, and UDI

  • Quality System Auditing experience

  • Strong technical writing skills; able to convey technical information clearly and effectively for management presentations and reports

  • Prior management experience preferred

  • Ability to travel periodically, including internationally (<10%)