Sr. Quality Engineer

About the role

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 improvement, disciplines, decisions, and practices. The Sr. Quality Engineer will manage and/or provide guidance to product sterilization, product testing, control environment/cleanroom testing, and actively participate in document changes, Corrective and Preventive Actions (CAPAs) and Complaints and Nonconforming Material Review process.

Responsibilities

• 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
• Manage and/or provide guidance to product sterilization, product testing and control environment/cleanroom testing.
• Analytical Problem Solving- ability to identify problems, define problem statements clearly and accurately, apply structured and disciplined methodology to identify data-driven root causes
• Manage and/or investigate and document CAPAs
• Update or create procedures, work instructions, forms and labels using Word, Excel, Label View, etc.
• Review and release sterile product
• Review document changes as assigned
• Support the compilation of technical and design history files
• Participate in external, internal, supplier and design history file audits, as needed
• Assign and review deviations.
• Support inspections and audits performed by Customers, FDA, Notified Body, OSHA
• May perform direct supervision of Quality Assurance staff
• Perform other duties as assigned by supervisor or manager

Requirements

Bachelor’s Degree required in a Technical or Scientific discipline. Minimum 8 years of experience in a medical device design and manufacturing environment. Ability to apply learned technology to products and processes.

Skills

• Software proficiency: Microsoft Word, Microsoft Excel, Adobe Acrobat, LabelView
• Strong background in FDA 21 CFR Regulations, ISO 13485, Health Canada Regulations, European Medical Device Regulations, ISO 14971
• Excellent verbal and written communication skills in English; ability to read, write and speak English to comprehend and execute internal Procedures, Drawings, Manufacturing Work Instructions (MWI), etc.
• Attention to detail and excellent organization skills