Company: Autocam Management Company
Posted on: January 16, 2022
- Establish and participate in supplier qualification/development
- Lead/Develop/Use Key Process Indicators to determine process
effectiveness, identify areas for improvement, best practices, and
drive continuous quality improvement.
- Lead/Drive corrective, preventive, and closure actions for
project issues related to quality and/or test non-conformance.
- Work closely with production line and ensure all necessary
controls are enforced to be compliant with ISO 13485 and FDA QSR
- May ensure that quality reporting (e.g. incoming and in-process
quality trends; returns analysis, categorization and corrective
action activity, etc.) is maintained and documented with the
- Perform analysis of reports and production data to identify
trends and recommend updates to changes to the Quality System
Regulations, Standards, and/or guideline procedures when necessary.
- Determines quality improvement parameters by identifying
statistical methods relevant to manufacturing processes.
- Establishes statistical confidence by identifying sample size
and acceptable error; determining levels of confidence.
- Develops sampling plans by applying attribute, variable, and
sequential sampling methods.
- Maintains statistical process controls by applying
demerit/unit, zone charting, and x2 charts for distributions and
individual-medial/range for multi-stream processes.
- Analyzes data by completing hypothesis, normal distribution,
and process capability analysis tests.
- Prepares reports by collecting, analyzing, and summarizing
data; making recommendations.
- Contributes to team effort by accomplishing related results as
- Strong interpersonal and presentation skills needed to interact
with external customers as well as with all levels within the
- Must demonstrate excellent writing skills with ability to
prepare/review and/or approve technical documentation.
- Thorough knowledge and experience surrounding quality control
- Previous Medical Device experience in a quality role is
preferred but not required.
- Thorough knowledge of ISO 9001 and ISO 13485 standards and FDA
21 CFR part 820
- Minimum Bachelor's Degree in an Engineering or Science
- Green Belt or ASQ certification a plus.
- Proven problem solving experience
- Ability to work in an entrepreneurial, fast-pace and rapidly
evolving environmentOur mission is to be the worldwide leader in
manufacture of precision components for customers
with whom we develop long-term business relationships.Our mission
will only be met by focusing on
continually improving our processes, thereby
improving our products and services to
meet and exceed our customer's expectations.The Quality Engineer is
responsible for understanding customer quality related
requirements, driving internal efforts for root cause and quality
improvement, while supporting our high standards of precision and
quality products in the inspection of medical parts.
Keywords: Autocam Management Company, Murfreesboro , Quality Engineer, Engineering , Murfreesboro, Tennessee
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