Duties: Subject matter expert, primary function of the Quality Specialist is to assist in maintaining the quality system; responsibilities such as:
• CAPA management, including investigation, documentation, and timely closure of exception reports.
• Global complaint handling process execution, including intake, evaluation, closure, and reportability.
• Complaint procedure writing and redlining to align with global regulatory requirements.
• Batch release support through GMP documentation review and compliance verification.
• Document control, including SOP writing, revision, and lifecycle management.
• Quality metrics collection, analysis, and reporting to support internal reviews and audits.
• Post-market surveillance data coordination and reporting.
• Batch and sample retention oversight in compliance with regulatory and internal standards.
• Cross-functional collaboration with internal teams, including the Medical Events Group, to resolve product quality issues and support regulatory responses.
Shift: Mon to Fri
Experience: 3-7 years, working with complaint/ med device… OUS/ Redline procedures/ Report ability/ experience/ CAPA… evaluation and closure/ reportability/ report the complaint file.. oversee the procedures… (Not Change control) (Not Manufacture QA)
Top 5 Skills/Requirements for the Resume: documentation proactive / compliant experience/ working cross function… Post Market Surveillance experience is as plus/ Analyst work
1. Experience in ensuring compliance with Quality Management Systems, including complaints coordination, batch release, exception reports, CAPA, document control, surveillance, testing, batch and sample retention, and metric maintenance.
2. GMP Documentation Review: Ability to review GMP-related documentation for compliance, including batch records, product manufacturing, testing and release, validation protocols, labels, product specifications, etc.
3. CAPA Process Participation: Experience in participating in the Corrective Action/Preventive Action (CAPA) process, including investigating failures or deviations in the manufacturing area.
4. SOP Writing and Revision: Skills in writing and revising Standard Operating Procedures (SOPs), controlled forms, and related documents to ensure best practices and alignment with current operations.
5. Quality Metrics Analysis: Ability to collect, analyze, and publish quality metrics, and provide data for support of budgetary submissions.
Preferred Experience: Direct experience in a Quality or Regulatory Affairs role in a GMP-related industry; Complaint handling experience and familiarity with ISO13485; Familiarity with electronic support systems such as TraqWise, GQMS, Salesforce, Excel, Powerpoint; Strong collaboration skills with internal groups to respond to product inquiries and issues; Participation in process or project-driven teams.
Education: Associate Degree (±) with complaint experience 3-7 years / Master degree may apply
“Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.”
If you are inclined, I would be happy to set up some time to chat more about your background and career interests to see if there could be a possible match. Please feel free to call me on 732-806-7467 or send me email on nirajk@mindlance.com
Regards
Niraj kumar
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