Participate in the New Product Development (NPI) and design changes, Design History File (DHF) and Device Master Record (DMR) reviews meetings and fully understand the design control process and Quality Engineering. Utilize technical training and compliance experience to ensure that company design control projects comply with internal design control procedures in accordance with FDA and ISO requirements.
ESSENTIAL JOB RESPONSIBILITIES AND DUTIES INCLUDE:
- Responsible for overall Design Quality process to ensure that company design control projects comply with internal design control procedures in accordance with FDA, ISO and other applicable requirements.
- Act as a subject matter expert on design control process and risk management process. Lead Risk Management activities from Product Concept through Commercialization.
- Provide guidance to internal and external stakeholders and ensure that design control requirements are being met in an effective manner in order to achieve quality by design, including those for design verification, validation, specification and procedure development, risk management, and design review.
- Lead & maintain high standards for Design History File (DHF) content completion, integrity, and regulatory / standards compliance. Collaborate with R&D teams to identify, communicate and resolve gaps.
- Establish the Design Control process for digital product family.
- Manage the team of Design Quality Engineer(s).
- Support the quality management system as required, including support Internal and External Audits.
REQUIREMENTS:
- Bachelor’s degree in Mechanical, Electrical or Biomedical Engineering, scientific or related discipline
- Minimum of 10 years’ experience in Design Quality or other related Quality Engineering function, within an FDA or ISO-13485 regulated manufacturing environment, and minimum of 3 years’ in a leadership role.
- Working knowledge of Medical Device Regulations: FDA 21 CFR 820, ISO 14971 & 13485, IEC 60601 series of standards, & other applicable regulations and industry standards pertaining to Medical Devices. Experience with IEC 62304 high desired.
- Experience with various quality tools such as Six Sigma DMAIC, FMEA, SPC, 8D Root Cause Analysis, FMEA, MSA & Gage R&R.
- Experience with manufacturing of complex medical device components & products, and with process validation (IQ/OQ/PQ).
- Ability to communicate ideas and information clearly, effectively, and concisely.
EDUCATION:
- BS in Mechanical, Electrical, or Biomedical Engineering or other scientific or related discipline
