Quality Engineer

POSITION: QUALITY ENGINEER (MEDICAL DEVICE)

MUST HAVES:
Needs BS in Engineering - Mechanical, Electrical, or Chemical
Medical experience
worked in a manufacturing environment
ASQ-CQE certification desirable

QUALIFICATIONS:

• Must be a U.S. Citizen or Permanent Resident, due to ITAR regulations in manufacturing plants
• Minimum Qualifications and Education Requirements
• Bachelor's Degree (B.S.) in Engineering, preferably Mechanical, Electrical, or Chemical from an accredited college or university.
  2+ years working experience in a manufacturing environment, preferably in Aerospace/Medical Manufacturing environment
• ASQ-CQE Certification is desirable, but not required.

ADDITIONAL QUALIFICATIONS:
Quality orientation and high attention to detail.
Excellent interpersonal and communication skills.
Experience working with high performance teams.
Problem analysis and problem resolution skills.
Must be familiar with Microsoft Word and Excel software.
Must be able to clearly present ideas and reports in written and verbal format.
Must be able to work well with subordinates, peers and superiors in all departments of the Company.

ESSENTIAL FUNCTIONS/RESPONSIBLITIES:

• Update documentation, train and implement quality processes such as MRB, RMA, CAPA and NCMR.
• Direct MRB activities including facilitating MRB, tracking non-conformances and analyzing NCMRs and RMAs.
• Perform analytical investigations and develop root cause for non-conformance and deviations as identified through scrap analysis, NCMRs and RMAs.
• Responsible for maintaining CAPA database.
• Coordinate RMA process including approval, verification upon receipt, disposition and issuance of subsequent CAPAs. Respond to customer related SCARs as required.
  Issue, monitor and evaluate CAPAs for effectiveness and timeliness.
• Create and/or process ECOs, process routers, drawings and other written documentation in accordance with quality system requirements.
• Monitor supplier performance through scorecard/grading, analyzing RI measurement data (SQC) and tracking NCMRs. Perform supplier audits and visits as required.
• Maintain internal auditing program to sustain certification to ISO standards while maintaining the effectiveness of the system.
• Responsible for internal, 3rd party, and customer audits.
• Analyze data and generate reports from ERP data using Minitab and Excel.
• Responsible for internal quality audits per ISO 9001, ISO 14001, AS 9100 and ISO 13485.
• Create validation protocols (IQ, OQ, PQ) execute protocols and document reports when required. Assist in DOEs, ANOVA and other analytical methods to optimize processes.
• Develop, document and train inspectors using internal procedures and GD&T guidelines. Design/specify gauging and test equipment for inspectors.
• Implement and maintain SPC and SQC using Infinity QS.
• Develop quality plans, pFMEAs, and FMEAs for new and existing products. Assist with developing control plans and other documentation during new product development.
• Conduct capability studies and complete variation reduction activities to improve processes.
• Compile and write training material and conduct training sessions on quality tools & techniques.
  Create/update RI & Final Product MIR cards for product
• inspection and testing.
• Set up, program and operate CMM and SmartScope, as well as other measurement/inspection tools. Improve measurement techniques and detection methods using GRR, MSAs, and poke-a-yoke

About Aerotek:

Our people are everything. As a Best of Staffing® Client and Talent leader, Aerotek® Inc. has distinguished itself as a leader in recruiting and staffing services, by having a deep understanding of the intersection of talent and business. As a strategic partner to more than 17,000 clients and 300,000 contract employees every year, Aerotek's people-focused approach yields competitive advantages for its clients and rewarding careers for its contract employees. Headquartered in Hanover, Md., Aerotek operates a network of over 230 non-franchised offices with more than 6,000 internal employees dedicated to serving our customers. Aerotek is an operating company of Allegis Group, a global talent solutions provider. To learn more, visit .

Aerotek is acting as an Employment Agency in relation to this vacancy.