TRS Consulting is supporting an Eagan, MN medical equipment manufacturer with their search for a Sr. Quality Engineer. This is a leadership role, responsible for a team of quality engineers.
The Senior Quality Engineer develops, establishes and maintains Quality Engineering methodologies, systems and practices that meet quality and customer requirements. This position will provide sound, systematic problem-solving methodologies in identifying, prioritizing, communicating and resolving quality issues. The role will drive quality improvements focused on New Product Introductions, Product Transfers and Marketed Product Support.
The Sr. Quality Engineer will support quality disciplines, decisions and practices, perform root cause analysis and identify appropriate actions for Corrective and Preventive Actions and Nonconforming Material systems, will be involved in complaints investigations, document changes, maintain the calibration system, supplier management, and will supervise Quality Inspectors.
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
REQUIRED EDUCATION & EXPERIENCE
Bachelor's Degree required in a Technical or Scientific discipline
Minimum 8 years of experience in a medical device design and manufacturing environment
Previous supervisory experience
Certified auditor or auditor training
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
Attention to details and excellent organization skills
Possess excellent verbal and written communication skills in English. Ability to read, write and speak English in order to comprehend and execute internal Procedures, Drawings, Manufacturing Work Instructions (MWI), etc.
Excellent Health, Dental, and Vision Insurance
Three weeks of PTO and 9 Paid Holidays
Retirement Savings, HSA, and FSA Options
Disability and Life Insurance Options
Voluntary Benefit Program
Flexible Hours and Collaborative Work Environment
Submit resume to firstname.lastname@example.org.