Overview
Quality Engineer Jobs in Elkhart, IN at Avero
Job Summary
Perform one or more of the following duties and responsibilities in support of company Quality Assurance program under minimal supervision.
EDUCATION/LICENSES
Doctorate degree or Master’s degree and 3 years of directly related experience or Bachelor’s degree and 5 years of directly related experience or Associate’s degree and 10 years of directly related experience or High school diploma / GED and 12 years of directly related experience
Preferred Qualifications
Educational background on engineering or life sciences.
Preferred Experience in Quality Assurance role.
Proficiency in Quality Management Systems
Technical Skills in:
Inspection Processes (automatic and manual)
equipment knowledge (engineering characterizations / system validations)
data analysis
manufacturing processes
document review and management
Soft Skills:
Attention to detail
Critical and Analytical Thinking
Cross functional collaboration
Strong communication
Responsibilities
Review and approve product MPs.
Approve process validation protocols and reports for manufacturing processes.
Request Quality on incident triage team.
Approve Environmental Characterization reports.
Release of sanitary utility systems.
Approve planned incidents.
Represent QA on NPI team.
Lead investigations.
Lead site audits.
Own site quality program procedures.
Designee for QA manager on local CCRB.
Review Risk Assessments.
Support Automation activities.
Support facilities and environmental programs.
Review and approve Work Orders.
Review and approve EMS/BMS alarms.
Approve NC investigations and CAPA records.
Approve change controls.
Provide lot disposition and authorize lots for shipment.
COMPETENCIES/SKILLS
Project management skills.
Strong organizational skills, including ability to follow assignments through to completion.
Initiate and lead cross functional teams.
Enhanced skills in leading, influencing and negotiating.
Strong knowledge in area of expertise.
Collaborate and coordinate with higher level outside resources.
Strong knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation and process development.
Demonstrate ability to interact with regulatory agencies.
Strong word processing, presentation, database and spreadsheet application skills.
Strong communication (both written and oral), facilitation and presentation skills.
Strong skill in working independently and to effectively interact with various levels.
Advanced data trending and evaluation.
Ability to evaluate compliance issues.
Demonstrate the Company Values/Leadership Practices.
Job Types: Full-time, Contract
Pay: $40.00 – $43.00 per hour
Expected hours: 40 per week
Schedule:
8 hour shift
Day shift
Monday to Friday
Overtime
Work Location: In person
Title: Quality Engineer
Company: Avero
Location: Elkhart, IN
