Quality Assurance Engineer

Description:
Chipton-Ross is seeking a Quality Assurance Engineer for a contract opportunity in Milwaukee, WI.


This position is 100% onsite.


BASIC QUALIFICATIONS (REQUIRED SKILLS/EXPERIENCE):
1 years in Quality system documentation
1 - 2 years reviewing and/or filing Quality records.
1 year experience processing large complaint datasets


POSITION RESPONSIBILITIES:
Ensure compilation and maintenance of product Design History Files. Perform DHF audits as an independent reviewer.
Archive Paper Device and Design History Records in Electronic Searchable format
Analyze Post-Market Quality Data (Complaint and Service Data), summarizing into easy to read failure analysis.
Document traceability of requirements through design output and to design verification and/or design validation.
Guide the use of robust statistical techniques throughout new product development and design changes.
Supports external regulator or customer audits
Performs other duties as requested.
Essential competencies:
2+ years relevant work experience.
Strong working knowledge of design controls as required by FDA 21 CFR 820.30 and ISO 13485
Demonstrated ability to analyze, evaluate and control risk following lifecycle risk management standards (e.g. ISO 14971).
Understanding of statistical analysis techniques and tools.
ASQ or related quality certification is preferred.
Work experience in an 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.
Detail oriented with good organizational and record keeping skills.
Ability to work independently and as part of a team.
Proactive and timely in the execution of assigned tasks.
Able to be flexible and adaptable when needs and priorities change

DESIRED EXPERIENCE:


REQUIRED EDUCATION:
Accredited HSD/GED
Bachelor's degree is highly preferred


WORK HOURS:
Full-Time
1st Shift
8:30AM-4:30PM

 
Job Number: 214646
Job Location: Milwaukee, WI
Rate: Up to $35.15 DOE
Duration: 12 months
Input Date: 06/06/2025
Last Updated: 06/09/2025
Firm Name: CHIPTON ROSS
Attention: Melody Mullins
Address: 420 CULVER BLVD
City, State: PLAYA DEL REY, CA 90293
Phone: 310/414-7800 X286
800 Phone: 800/927-9318
Fax Phone: 310/414-7808
Email: mmullins@chiptonross.com
Website: www.chiptonross.com
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