Senior Quality Engineer
Senior Quality Engineer
DAVIS Companies has partnered with a leader in Otology equipment manufacturing, to identify a Sr Quality Engineering to join their growing team! This is a direct hire opportunity. Local candidates only please.
The Sr. Quality Engineer develops, establishes and maintains Quality Engineering methodologies, systems and practices that meet quality and customer requirements. The Sr. QE drives quality improvements focused on New Product Introductions, Product Transfers and Marketed Product Support. This position will provide sound, systematic problem-solving methodologies in identifying, prioritizing, communicating and resolving quality issues. Supports quality disciplines, decisions and practices. The Sr. Quality Engineer will perform root cause analysis and identify appropriate actions for Corrective and Preventive Actions (CAPAs) and Nonconforming Material systems, will be involved in complaints investigations, document changes, maintaining the calibration system, supplier management, and will supervise Quality Inspectors
Essential Duties and Responsibilities of the Sr Quality Engineer:
• Follow all regulations, standards, procedures and work instructions defined in the Quality System Manual
• Sound knowledge of inspection principles and techniques
• Sound knowledge of validation principles
• Ability to interpret Quality Standards for implementation
• Analytical Problem Solving- ability to identify problems, define problem statements clearly and accurately, apply structured and disciplined methodology to identify data-driven root causes
• Investigate and document CAPAs
• Update or create procedures, work instructions, forms and labels using Word, Excel, Label View, etc.
• Maintain the Calibration System
• Review and release sterile product
• Review document changes as assigned
• Support the compilation of technical files including usability engineering reports, risk management files, etc.
• Perform internal, supplier and design history file audits, as needed
• Evaluate and Assess Suppliers
• Assign and review deviations
• Support inspections and audits performed by Customers, FDA, Notified Body, OSHA, etc.
• Perform other duties as assigned by supervisor or manager
Education & Experience Requirements of the Sr Quality Engineer:
• Bachelor’s Degree required in a Technical or Scientific discipline
• Minimum 8 years of experience in a medical device design and manufacturing environment
• Software proficiency: Adobe Acrobat, LabelView, BarTender
• Strong background in FDA 21 CFR Regulations, ISO 13485, Health Canada Regulations, European Medical Device Regulations, ISO 14971
Preferred Skills & Abilities
• Previous supervisory experience a plus, but not required
• Certified auditor or auditor training