USA - Quality Assurance Engineer I- CTQ

Equiliem
United States, New York, Skaneateles
Mar 26, 2025
Top 3-5 Must Have Non-negotiable Skills Required 1. Ability to work unsupervised, strong work ethic, self-starter 2. Experience working with data, comfortable with data analyst 3. Comfortable reading and understanding blueprints and other technical data 4. Strong interpersonal skills and attention to detail 5. Organized and be able to multi-task. Is a bachelor's degree Required? - Not required, but degree is preferred. I would reference the requirements that we have for our quality analysts, see below. How many years of recent experience does this person need to have? See above Nice to Have Skills 1. Project management experience 2. Experience working with FDA regulations or other regulated fields 3. Supplier quality experience Location: (100% remote allowed or is hybrid work needed? If onsite, what location?) Hybrid - 50% remote, 50% at Skaneateles Falls Job Title: Quality Associate - Supplier Quality Job Description: Self-sufficient go-getter with quality mindset. Associate will be working closely with the supplier quality team to address gaps within supplier quality and distribution systems. They will be expected to pull and review data and work with internal and external groups to implement solutions. Prior experience within manufacturing environment and data analytics is strongly desired. Ability to read and interpret blueprint requirements is a plus. Position Summary: The Quality Assurance Engineer provides technical support for various quality system processes to help ensure excellent product quality throughout product lifecycles. Position Responsibilities: Drive continuous improvement actions focused on product quality. Works with Engineering and Manufacturing to develop acceptance criteria for production processes. Works with Service and the Complaint Handling Unit to investigate product problems, perform root cause analysis and identify possible corrective actions. Analyzes production quality data to identify trends or issues which require action or CAPA activity. Assists in creating and implementing procedures in the quality management system. Assists in the review and disposition of nonconforming materials. Assists in the creation and validation of manufacturing processes. Conducts internal audits of production processes and report results. Reviews manufacturing process and part deviations. Creates quality alerts when acceptance activities need to be adjusted. Supports external regulator or customer audits Provides response to inquiries related to quality assurance arising from tenders or other sales efforts. Performs other duties as requested. Essential competencies: Bachelor of Science degree in Engineering or related field. 3+ years relevant work experience. Demonstrated ability to analyze, evaluate and control risk following lifecycle risk management standards (e.g. ISO 14971). Experience with manufacturing / quality methodologies such as QFD, six-sigma, lean, etc. Understanding of statistical analysis techniques and tools. Experience with formal quality systems such as ISO 13485 or ISO 9001. ASQ or related quality certification is preferred. Work experience in a FDA regulated environment is preferred. Proficiency in reading and understanding technical product documentation (diagrams, schematics, flow-charts, etc.) Proficient in the use of Microsoft Office tools such as Word, Excel, PowerPoint, Outlook, etc. Comfortable with using PC tools and Windows OS, with a working knowledge of local and network based file systems. Excellent verbal and written communication skills using the English language. Able to coordinate multiple activities and actions of persons contributing to assigned tasks. Detail oriented with good organizational and record keeping skills. Ability to work independently and as part of a team. Proactive and timely in execution of assigned tasks. Able to be flexible and adaptable when needs and priorities change Physical demands and work environment: Physical Demands: While performing the duties of this job the employee will be sitting for extended periods, will need to use a computer/mouse/keyboard/monitor and will communicate and listen both in-person and over the phone. Work environment: The work environment is in an office setting with minimal noise level.