Quality Engineer
Quality Engineer
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Job Description
WeCare Medical Specialty Group is seeking a detail-oriented and experienced Remote Quality Engineer to support our ongoing efforts in quality assurance process improvement and regulatory compliance. The ideal candidate will play a critical role in maintaining and enhancing the quality systems that support our clinical operations medical services and regulatory adherence across multiple departments.
As a key member of our Quality Assurance team the Quality Engineer will lead and support quality initiatives perform risk analyses support CAPA investigations and ensure continuous improvement in service deliveryall while working remotely within a collaborative mission-driven environment.
Key Responsibilities
Quality Systems Management
Maintain and support the organizations Quality Management System (QMS) in accordance with applicable regulations (e.g. HIPAA FDA ISO 13485 and internal policies).
Conduct internal quality audits and prepare reports with findings and corrective actions.
Monitor compliance across departments and ensure documentation standards are upheld.
Process Improvement & Risk Management
Analyze processes and procedures to identify inefficiencies risks and opportunities for improvement.
Facilitate root cause analyses (RCA) and implement Corrective and Preventive Actions (CAPA).
Use Lean Six Sigma or other quality methodologies to improve workflows and outcomes.
Product & Service Quality Oversight
Evaluate quality metrics and ensure medical services and support products meet defined performance criteria.
Collaborate with cross-functional teams (clinical operations IT) to ensure alignment with quality standards.
Contribute to the development and review of protocols standard operating procedures (SOPs) and quality documentation.
Training & Support
Provide training and support to team members on quality-related tools and standards.
Lead remote workshops and quality review meetings.
Serve as a point of contact for quality concerns and regulatory inquiries.
Qualifications
Required:
Bachelors degree in Engineering Quality Assurance Life Sciences Healthcare Administration or a related field.
Minimum 3 years of experience in a Quality Engineer or Quality Assurance role preferably in healthcare life sciences or medical services.
Strong knowledge of regulatory standards such as HIPAA FDA ISO 13485 or similar quality frameworks.
Experience with QMS software tools data analysis and process mapping.
Demonstrated ability to lead CAPA investigations and conduct risk assessments (e.g. FMEA).
Excellent written and verbal communication skills.
Self-motivated and capable of working independently in a remote setting.
Preferred:
Certified Quality Engineer (CQE) Lean Six Sigma Green or Black Belt or equivalent.
Experience in remote or hybrid work environments.
Familiarity with healthcare operations medical terminology or clinical workflows.
Proficiency in tools such as Microsoft 365 Google Workspace Jira Smartsheet or Q-Pulse.
Work Environment & Compensation
Work Environment:
Fully remote position with occasional virtual team meetings and optional in-person retreats.
Must have access to a secure high-speed internet connection and quiet workspace.
Compensation & Benefits:
Competitive salary based on experience and qualifications
Health dental and vision insurance
401(k) with company match
Paid time off (PTO) holidays and sick leave
Professional development and certification reimbursement
Flexible working hours within core business time
Employment Type
Full Time
