USA - Quality Assurance Engineer I- CTQ
USA - Quality Assurance Engineer I- CTQ
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1 Vacancy
Job Description
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.
Additional Details
- Client Bill Rate : 42.00
- Does the position allow for the worker to be virtual/remote : No
- Shore Options Available for this Position : Onshore Only
- Direct or Indirect : Indirect
- Kronos Worker : No
- Shift : USA-1
About us: DivIHN the IT Asset Performance Services organization provides Professional Consulting Custom Projects and Professional Resource Augmentation services to clients in the Mid-West and beyond. The strategic characteristics of the organization are Standardization Specialization and Collaboration. DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race color religion (creed) gender gender expression age national origin (ancestry) disability marital status sexual orientation or military status.
Employment Type
Full-time
Key Skills
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