Government, Regulatory and Code, Healthcare, Quality, Quality Engineering
4 Year Degree
We are a rapidly growing medical device company which is seeking a highly-motivated Associate Quality Engineer to work in a fast-paced environment that fosters teamwork, change, risk-based decision-making and flexibility.The Quality Engineer will support all new product development activities and associated manufacturing processes and will actively participate in continuous improvement and support activities of existing products.This individual will develop and improve on risk assessment, inspection methodology and acceptance criteria for inspection sample plans.The Quality Engineer will be able to communicate effectively at all levels within Quality as well as cross functionally with departments such as R&D, Regulatory, Operations & Manufacturing, and Marketing.
Help develop, qualify, and validate methods of inspection, testing, and evaluation.
Help establish internal and external inspection requirements.
Review, approve, and implement inspection plans.
Support product design transfers to contract-manufacturers/suppliers.
Work with suppliers to establish & manage required gauges.
Participate in risk analysis activities at different phases of products development, production and commercialization.
Participate in the review and approval of Engineering Change Orders and design control documentation.
Participate in Product Design Verification & Validation.
Participate in analyzing customer’s complaints to determine root cause.
Participate in handling MDRs.
Participate in reviewing collected data and trends to make them available for the periodic update of product Risk Management (ISO 14971).
Participate in maintaining and monitoring the following quality systems and supporting documentation: Audit system, CAPA system, FDA QSRs system and ISO 13485 system.
Participate in the review, update, and implementation of procedures affecting quality assurance.
Participate in the review of external reference documents related to the company Quality Management System to ensure that necessary updates are applied to the company procedures and implemented.
Participate in developing internal training sessions on quality and compliance issues as necessary.
Inspection of material- receiving inspection and in-process inspection.
Assist in the completion of documents and/ or in the of paperwork required by FDA, Notified Body, or other regulatory agencies, following good documentation practices.
Enter data into the electronic document management systems .
Working knowledge of FDA QSRs, ISO 13845, MDD and/or other international medical device regulations desired, and the application of advanced quality tools such as Failure Modes Effect Analysis (FMEA) and Root Cause Analysis.
Ability to effectively work cross-functionally with Product Development, Operations, Marketing and Production departments.
Excellent problem solving and troubleshooting skills.
Excellent interpersonal and communication skills.
Work independently, with leadership qualities.
Must be positive, energetic team player, and an advocate for product excellence and quality.
Candidate must be results oriented, quick learner, respond to the urgent needs of the team and show a strong track record of meeting deadlines.