Senior Quality Operations Lead
OneTrust
full-time
Posted on:
Location Type: Office
Location: Cornelia • United States
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Job Level
About the role
- Plans, coordinates, and directs quality assurance programs designed to ensure continuous production of products consistent with established standards.
- Serves as the Quality Operations Site Lead and overseeing day-to-day quality operations.
- Verifies that the Quality System is in place and maintained at the required compliance level.
- Drives Quality System efficient execution and reduced risk of non-conforming product.
- Establishes and maintains quality assurance programs, procedures, and controls.
- Ensures that performance and quality of products conform to established company and regulatory standards.
- Analyzes data sources significant quality trends and recommends actions as needed.
- Reviews and approves non-conformances, CAPA, Audit Observations, Change Controls, Validations and Completion Reports, and other quality system documents or records as required.
- Manages the qualification and validation for all products and processes and quality control support activities.
- Supports investigation, evaluation, and implementation of actions to eliminate root causes of non-conformances.
Requirements
- A minimum of a Bachelor or Equivalent University degree is required.
- Generally, Requires 8-10 Years Work Experience
- Bachelor’s degree in a Technical or Science field
- Eight (8) years active management experience including direct supervision and matrix management
- Thirteen (13) years related experience and/or training or an equivalent combination of education and experience
- Experience in front-room role with FDA (or similar) inspection and Notified Body inspection
- Successful management of a multinational department and/or significant QA project
- Statistical and analytical problem solving.
- Certified in PE tools (preferred)
- Preferred knowledge of lean manufacturing and manufacturing processes
- Excellent oral communication and technical writing skills
- Good decision-making skills.
Benefits
- Health insurance
- 401(k) matching
- Flexible work hours
- Paid time off
- Professional development
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
quality assurancedata analysisCAPAaudit observationschange controlsvalidationsstatistical problem solvinglean manufacturingquality controlrisk management
Soft Skills
communicationdecision-makingleadershipsupervisionmatrix managementproblem solvingcoordinationorganizationevaluationimplementation
Certifications
PE tools certification