Quality Engineer II

 

Responsibilities:

Participates as a member of the facility's Audit Team in performing internal and external audits as required.Prioritize responsibilities and establish timelines in order to maintain a balance of support in all projects and execute projects with clear objectives.Participates in product design control activities for new product lines.Conducts risk analysis (Fault Tree, FMEA, FMECA, Hazard analysis or equivalent accepted methods) as part of design control for new and existing product lines to identify potential hazards associated with the device design under both normal and fault conditions.Works on problems of moderate scope where analysis of situation or data requires a review of a variety of factors. Exercises judgment within defined procedures and practices to determine appropriate action.Builds productive working relationships.Ensures compliance to all state and Federal regulations and requirements.Generates, reviews and revises procedures, SOPs, drawings, equipment specifications, Engineering Test Reports (ETR) and technical reports.Proficiently develops and performs testing and evaluation of process validations using Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualification (PQ). Documents all activities in compliance with validation procedures.Maintains and assists in establishing standardized methods and procedures for process, and test method validations and ensure standardized methods are implemented and followed.Availability to travel to learn role, product line processes, conduct validations, studies, and/or audits whenever it is required. Up to 40% travel until October 2024.

 

Qualifications:

Bachelor's Degree required, preferably in Mechanical, Electrical, Electromechanical, or Biomedical Engineering. Advanced Degree desirable Minimum 2-5 years of combined Quality Engineering, Pharmaceutical manufacturing, medical device manufacturing and/or laboratory (organic chemistry, analytical, and/or microbiology) experience preferred. With a Master's Degree no prior work experience may be necessary.Must have strong technical and analytical skills.Good understanding of software management Tools, spreadsheets, and word processing software.Problem solving and Root Cause Analysis.Ability to understand and employ mathematics at an engineering or scientific level. Ability to define problems, collect data, establish facts, and draw valid conclusions.Good understanding of software management Tools, spreadsheets, and word processing software.Ability to effectively present information to upper management and other groups.Ability to write reports, business correspondence, and procedures. Must be able to prepare clear and informative engineering and technical reports with accuracy.Experience with Correlation and regression Analysis, Experimental Design (DOE), and acceptance sampling; as well as conducting and interpreting gage R&R studies.Good working knowledge of production processes, SOPs, drawings, machine specifications, and required test equipment/fixtures.Perform process capability studies.Software: minitab, Microsoft (Excel, Word, etc), SAPU.S.A Visa required.Availability to travel to the U.S. and other country if required.