Regulatory Job 560884-Complaint Leader

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560884-Complaint Leader MD 55 - 118k (J#13314)
Education: Bachelors Degree
Experience: 1 - 3 years

Essential Functions (Responsibilities):
Lead and/or Coordinate Product Quality activities as assigned, to include, but not limited to:
-Complaint Data Collection
-Complaint Evaluation
-Complaint Investigation
-Complaint CA/PA Planning, Execution, and Effectiveness Checks
-Complaint File Closure and Trending
-Adverse Event Reporting
-Product Field Action Reporting and Execution

Support regulatory compliance and optimization of quality system procedures relating to product complaint handling, adverse event reporting & product field actions, through:
-Development, maintenance and improvement of documented processes.
-Development and implementation of employee training.
-Development and implementation of quality metrics to drive improvement and business results.

Support key QA/RA activities, as assigned. May include, but are not limited to activities in the following areas:
-Product/Incident Risk Assessments
-Training
-Internal Auditing
-Quality Metrics

Qualifications/Requirements:
- Bachelor's Degreein a clinical field, or Associate's degree and a minimum of 3 years of Quality Assurance/Regulatory Affairs experience in medical device, clinical, or pharmaceutical industry including:
- Knowledge and experience applying US drug and device laws and standards including, FDA 21 CFR, ISO 13485, Medical Device Directive, and Canadian Medical Device Regulations).
- Corrective and Preventative Action processes. Handling of product complaints. Handling of adverse event reporting.
- Demonstrated experience with root cause of problem identification and creative problem solving to gain resolution.
- Prior experience using spreadsheet and presentation software.
- Must apply for this position at www.gecareers.com.
-Must be willing to take a drug test.
- Must be willing to submit to a background investigation, including for example, verification of your past employment, criminal history, and educational background.
- Must be legally authorized to work in the United States.
- Must be willing to work at our location in Laurel, Maryland, and to travel up to 10% of time, as needed.
Desired:
-Experience in handling of field action reporting (e.g., recalls).
-Experience with Training and course development.
-Ability to adapt to constant change.
-Ability to influence positive change effectively.
-Familiar with Continuous Improvement methodologies, including Six Sigma.
- Ability to communicate effectively (both written and oral).
- Team-oriented and responsive to customer needs.
- Working knowledge of English language (oral and written).
- Ability to work independently in fast-paced environment with little supervision.

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