Consultant, Quality Engineer, EU MDR, Medical Device
Company: GForce Life Sciences
Posted on: October 13, 2019
SummaryOur client, a growing medical device company, has engaged
GForce Life Sciences, to identify a strong Quality Engineer to
support the implementation of Medical Device Regulations (EU)
2017/745 requirements. This will entail resolving issues by
identifying and applying solutions from acquired technical
experience and guided precedents. Coordinate customer requirements
and assist in the coordination of projects with other quality
engineers. Work effectively & productively with all departments by
developing a team atmosphere.
Duties / Expectations of Role
The Quality Engineer should be familiar with quality function,
process flows, control plans, build instructions, process
verification and validations (IQ/OQ/PQ), and quality inspection.
- Coordinate customer requirements, spreadsheets, and
documentation to reach their MDR compliance.
- Coordinate activities between other contracted QEs
- Validating document testing, process flow and document
- Plan and coordinate the project tasks and resolve/escalate
- Report the project progress to the site leads.
- Chosen QE(s) will implement, communicate, execute, receive,
review, track, report, and archive all documentation as objective
evidence as requested for purpose of compliance to EU MDR,
Corporate Procedures, 21 CFR Part 820.50 and 21 CFR Part
- Ensure customers and the organization are EU MDR compliant via
objective evidence/documentation gathered over the course of the
- Bachelor of Science in Engineering or an alternative Bachelor's
degree program with certification as a quality engineer (e.g.
- 5+ years of experience in a Quality Engineering role within
- Experience working in a Supplier Quality or Continuity
- Working understanding of QSR/ISO regulations, design assurance,
FMEA, Process Flow, and product testing methods.
- Experience in process validations: creating, reviewing, and
approving protocols and reports, and execution of protocols.
- Experience to include all components of production and process
controls including, IQ, OQ, PQ, PPQ, manufacturing equipment
software (CSV), and TMV/MSA.
- Experience in pFMEA, manufacturing process flows, control
plans, and quality records are required.
- Expert knowledge of blueprint reading and geometric
dimensioning and tolerancing
- Knowledge of statistics, manufacturing process control and
validation, and process capability
- Medical device manufacturing experience
- Ability to work within a team environment and build
relationships outside of the department as well as outside the
company (suppliers, regulatory agencies, etc.).
- Ability to deliver, meet deadlines and have results
- Able to communicate both orally and in written form to multiple
levels of the company.
- Microsoft Office Suite Experience
Nice to Have Requirements
- Certification as a quality engineer (e.g. CQE) or the
Reliability Engineer Certification (CRE) granted through the
American Society of Quality (ASQ) preferred.
- Knowledge of medical manufacturing, specifically related to ISO
13485, is desired.
- Understanding of Medical Device Regulations (EU) 2017/745,
- Working knowledge of ISO 13485
- Working knowledge of 21-CFR-820
- Working knowledge of FDA Design Controls/ISO13485 and medical
device product development
Term & Start
- 7 months+
- Start ASAP
- IN or Remote Work is a possibility
Keywords: GForce Life Sciences, Indianapolis , Consultant, Quality Engineer, EU MDR, Medical Device, Professions , Indianapolis, Indiana
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