Quality Engineer
MicroGEM -
Charlottesville, VA
engineer
data
engineering
regulatory
conforming
technical
analysis
compliance
education
level 4
travel
engineer
operations
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March 2, 2023
MicroGEM -
Charlottesville, VA
OTHER
Job Details
Job Location: MICROGEM VA - Charlottesville, VA
Position Type: Full Time
Education Level: 4 Year Degree
Salary Range: Undisclosed
Travel Percentage: Negligible
Job Shift: Any
Job Category: Engineering
SUMMARY OF ROLE
The Quality Engineer will be work closely with Operations, Suppliers, and other functional areas within the company to evaluate actual and potential product failures and update risk management files as needed.
TYPE: Full Time
LOCATION: Hudson, New Hampshire, Ogden, Utah, and Charlottesville, Virginia
THIS ROLE WILL REPORT TO: Vice President of Quality and Regulatory
RESPONSIBILITIES:
- Assure product quality across the supply chain by evaluating non-conforming material, identifying and resolving quality issues, and driving process/product changes
- Develop deep technical and historical knowledge of the product and applying it to decision making and/or process reviews
- Partner with Manufacture and the Product Specialist while leading CAPA efforts to provide robust root cause analysis when reviewing in-process reject trends, non-conforming product, and post market surveillance data
- Maintain risk documentation by continually assessing the current data and ensuring designs and processes are reducing risk
- Maintain and optimize test methods in order to ensure safety, effectiveness, compliance and efficiencies within the production environment
- Employ statistical techniques to promote data driven decisions and to identify trends or issues requiring action, CAPA activity, or trending
- Provide technical support and collaborate with other functions such as Quality, and Regulatory to ensure/maintain compliance (e.g., audit and submission support)
- Participate in audits and inspections as requested
PREFERRED EXPERIENCE:
- Bachelor's (Required)
- 3 years experience in a Quality Engineering role - CQE preferred
- Knowledge of continuous improvement methodologies and various quality tools & systems; Lean, Six Sigma, Pareto Analysis, FMEA, PPAP, 8D, Problem Solving Lean - Six Sigma Green or Black Belt preferred
- Experience developing work instructions and relative QMS procedures.
- 5 years experience in manufacturing of medical devices or related field
- CGMP and GDP Competency
- Strong interpersonal communication skills
- Proficiency with Microsoft Office
- Some weekends may be needed
- Experience working under ISO 13485 or ISO 9001 certification
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