Quality Engineering Manager

Job Title: Quality Engineering Manager

Job Number: 33793

Location: , 

Job Description

Responsibilities

● Lead Quality Engineering guidance and oversight for medical devices during feasibility, all phases of design control, risk management, human factor/usability engineering, process development and verification/validation testing, as well as life cycle management during design changes. ● Lead device development team to define critical to quality characteristics for device components and finished devices. ● Lead Quality review and approval of all technical documentation for design and development technical and risk management documentation, e.g., planning, traceability matrix, protocols, reports, risk assessments, testing, etc. through applying applicable company procedures and regulatory requirements. ● Provide input to process manufacturing design and design transfer to ensure compliant, robust product realization

Required Skills

Experience in medical device design, development technical oversight, and related risk assessment/management throughout the product life cycle ● Quality oversight experience of device processes and documentation ● Working knowledge and application of device regulations, including 21 CFR 820, 2017/745, ISO 13485, ISO 14971. ● Experience in supplier management and relations, including quality agreement generation and maintenance ● Working knowledge of process development and validation principles ● Experience in hazard analysis and application of risk analysis tools such as FMEA, Fishbone, etc. ● Experience with regulatory inspections and interaction with regulatory authorities ● Experience in Change Control and CAPA applications