- 214646 - Quality Assurance Engineer
- Industry
- ENG
- Region
- WI-Wisconsin
- City
- Milwaukee
- State
- WI
- Rate
- Up to $35.15 DOE
- Duration
- 12 months
- 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
Employment will be contingent on clearing a drug screen and background check. Both must clear prior to start date.
- Contact
-
Melody Mullins
mmullins@chiptonross.com
CHIPTON-ROSS, INC.
6926 Rivers Ave
North Charleston, SC 29406
Phone: (843) 554-5800 x186 or (800) 927-9318 x186
Candidates responding to this posting must currently possess the eligibility to work in the United States. No third parties please.
Employment will be contingent on candidate clearing pre-employment drug screen and background check.
Chipton-Ross provides equal employment opportunities to all employees and applicants for employment without regard to race, color, creed, religion, national origin, sex (including pregnancy), age, disability, sexual orientation, gender identity and/or expression, protected veteran status, genetic information, or any other characteristic protected by Federal, State or local law. This policy governs all areas of employment at Chipton-Ross, including recruiting, hiring, training, assignment, promotions, compensation, benefits, discipline, and terminations.