Principal Quality Engineer

Avedro Inc - Waltham, MA2.0

30+ days agoFull-time
About Avedro:
Avedro is a privately held pharmaceutical and medical device company advancing the science and technology of corneal cross-linking and refractive correction. Avedro’s Photrexa Viscous, Photrexa and KXL products are approved for sale in the United States for the treatment of progressive keratoconus and corneal ectasia following refractive surgery.

Avedro’s products sold outside of the United States include capital equipment such as the UV-X devices, the KXL and Mosaic™ Systems, and related proprietary pharmaceuticals such as the VibeX® and MedioCROSS® formulations. Avedro distributes its products in countries outside of the United States through a network of ophthalmic medical device distributors.

Position Summary: This highly motivated candidate will be responsible for providing quality engineering support in design, development and commercialization of medical device products, as well as management of quality aspects of design controls - ensuring that there is clear traceability from design planning to commercialization. This candidate will manage design control and master validation process and documentation including the validations of Production processes and tooling documentation, MVP, IQ, OQ, PQ, PPQ, and Test method validation. Excellent interpersonal and communication skills, as well as the ability to manage across functions, and multidisciplinary projects will be key for this role.

Additional job duties:
Ensure robust final product testing is designed, developed and implemented.
Review design history technical files for conformance to applicable requirements and regulatory standards.
Review all design changes to ensure that the documentation includes the necessary justifications, validation and verification updates, risk assessment etc.
Create a risk management plan, perform product risk assessment, facilitate the failure mode effects analysis, and create a final risk management report.
Implement and support product reliability assessments.
Facilitate the application of design controls in product development and sustaining changes.
Review new or modified product designs for quality characteristics, including manufacturability, serviceability, testability, reliability, and product requirements.
Provide support for product complaint investigations and ensure rapid resolution of product complaints and/or safety issues.
Manage risk management process and post market feedback review and updates.
Continuously improve the risk management process.
Perform and/or support audits (internal, external, and by regulatory agencies) and risk-based supplier assessments.
Provide product understanding and support during audits.

Education and experience requirements:
Bachelor of Science / Bachelor of Arts (or equivalent) required; Master’s or advanced degree preferred.
5-10 years of Medical Device and / or Pharmaceutical Experience required.
Knowledge of ISO 13485, 21 CFR 820, CMDR, MDD and 21 CFR 210 and 211.
Experience with Medical Device capital equipment preferred.
Experience with test methods and standards for the design, verification, and validation of medical device products.
Experience in risk evaluation and investigation techniques, such as FMEA, fault tree analysis, 5 Why’s, Fishbone, HACCP etc.
Skilled in statistical methods, gauge R&R, statistical process control, sampling plans, and design of experiments.