Quality Engineer
Company: Medartis, Inc.
Location: Warsaw
Posted on: January 24, 2023
Job Description:
PURPOSE: Contributes to the project teams by reviewing prints,
risk assessments and quality planning. This includes communication
with Engineering on inspection methods, materials and suppliers. -
- - - - - - - - - - GENERAL RESPONSIBILITIES:
- Follow and assure that personnel comply with FDA Quality
Systems Regulation, ISO Standards and SOP's as defined by
Nextremity's policies, practices and procedures.
- Independently inspect components and finished goods for
compliance to specifications.
- Apply quality-engineering techniques on new and/ or existing
products. - Assure all products meet or exceed customer
requirements.
- Work with suppliers to resolve non conforming issues or other
matters related to supplier corrective actions, material review
board and/or CAPAs.
- Ensure that all record keeping and documentation is completed
in a timely manner according to established policies, practices and
procedures.
- Continuously review methods, procedures, processes, etc. to
determine improvements related to quality and cost to increase
efficiencies. - Make recommendations and, upon approval, implement.
- Motivate subordinates to recommend improvements.
- Review changes to products in production for reliability impact
to aid in the correction process, design or material problems.
- Working knowledge in spreadsheets, databases and word
processing software programs.
- Authorized to represent the Quality Department in signing off
on Change Orders.
- Maintain effective working relations, communications and
feedback with all other departments.
- Perform other duties as required. SKILL AND EDUCATION
REQUIREMENTS:
- 3-5 years' experience in Quality Engineering or Supplier
Quality.
- BS in Engineering or related field or equivalent in experience
and training.
- In depth knowledge of quality system and ISO requirements --- -
- Knowledge of basic statistical and engineering principals is
essential.
Keywords: Medartis, Inc., South Bend , Quality Engineer, Engineering , Warsaw, Indiana
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