Manufacturing Quality Specialist (2nd Shift)

Added
8 days ago
Type
Full time
Salary
Salary not provided

Related skills

quality assurance iso 9001 root cause analysis iso 13485 capa
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πŸ“‹ Description

  • Implement process controls and audits in oligo manufacturing.
  • Collaborate with cross-functional teams to ensure regulatory compliance.
  • Support customer complaints and product returns investigations.
  • Back-up QC technician and perform final QC checks on VIP orders.
  • Conduct manufacturing process audits for risk and compliance.
  • Lead CAPA investigations and track corrective actions.

🎯 Requirements

  • Bachelor's in engineering, Life Sciences, Chemistry, or related field; Master’s preferred.
  • 3+ years in quality assurance/manufacturing quality control in regulated industry.
  • Working knowledge of 21 CFR 820, ISO 9001, ISO 13485.
  • Experience with quality audits, nonconformance management, root cause analysis.
  • Strong problem-solving skills and CAPA leadership.
  • Excellent attention to detail and cross-functional collaboration.

🎁 Benefits

  • Schedule: Tue-Sat, 3 PM-12 AM.
  • Medical, dental, and vision coverage.
  • Life and disability insurance.
  • 401(k) with company match.
  • Paid vacation and holidays.
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