- Perform QA process Improvements to ensure effective and efficient process flow, training, etc. for new projects and help improve existing QA projects.
- Recommend, innovate and implement revised methods and processes.
- Responsible for creating new procedures related to metrology.
- Validation- review and approve manufacturing validations (IQ, OQ, PQ) for new products and carry out QA validations.
- Nonconforming Material – drive closure of NCMR's, improve processes to reduce/mitigate NCs, and provide trend reports to management
- Assist in CAPA closures, including track and trend, provide status updates with respect action items identified within the investigation.
- Assists in execution of internal and supplier audits.
- Perform Risk Analysis and manage Risk Mitigations for raw material and components made for customers.
- Assists and provide technical assistance
- Perform/complete PFMEA's and generate/improve internal Control Plans.
- Performs cross functional tasks until appropriate resources are in place, or as directed by management.
- Bachelor's degree in Engineering or equivalent
- Minimum 2-3 years work experience in quality, manufacturing, or engineering with proven track record in CIP, IQA and CAPA processes.
- Green Belt or Black Belt skills a plus.
- Understanding in GD&T
- Statistical Analysis ability (MSA, normality test, confidence/reliability)
- Ability to perform Root Cause Analysis (8D, Fishbone, 5 Whys).
- A general understanding of Lean practices in manufacturing environment.
- Quality Certification a plus.
- Comfortable with complex technical analysis.
- Ability to travel approximately 5-10% of the time.
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Quality Engineering Specialist - Stafford, United States - Astrix
Description
Great development opportunity to work for a leading global consumer-centric medical device company is looking for a Quality Engineering Generalist. This is your chance to work with a global company with nearly 13,000 employees located in 30 countries
Quality Engineering Specialist/Generalist
Schedule: Monday-Friday 8a-5p
Qualifications
This job description is a complete list of all desired skills but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you
