Quality Specialist II
3 weeks ago
Quality Specialist
Are you a detail-oriented quality professional with a passion for ensuring excellence?
Atlas Lift Tech is seeking a Quality Specialist to support our commitment to delivering top-quality products and services. In this role, you will play a critical part in maintaining compliance with industry standards and regulations.
Responsibilities:
- Initiate and manage quality-related processes including deviations, CAPAs, and change control.
- Contribute to the complaint program by tracking, trending, and completing regulatory risk assessments.
- Oversee supplier quality activities and maintain relevant documentation.
- Conduct root cause analysis and support continuous improvement initiatives.
- Manage document control, including creation, revision, and distribution of controlled documents.
- Assist with regulatory filings and maintain controlled document libraries.
- Coordinate change orders and conduct process walks.
- Collaborate with cross-functional teams to achieve quality objectives.
Qualifications:
- Bachelor's degree required with a minimum of 3 years of experience in a regulated environment (medical devices preferred).
- Strong understanding of Quality Management Systems (QMS) and Medical Device Regulations (CFR 820, ISO 13485).
- Excellent attention to detail and organizational skills.
- Ability to prioritize tasks and meet deadlines.
- Strong written and verbal communication skills.
- Proficiency in relevant software applications.
- Quality certification (preferred).
Ready to make a difference? Join our team and enjoy a challenging and rewarding career opportunity.
We offer a competitive compensation package, including benefits and opportunities for professional growth.
Keywords: Quality Specialist, Quality Assurance, Quality Control, Regulatory Affairs, Medical Devices, QMS, ISO 13485, CFR 820, CAPA, Change Control, Document Control, Root Cause Analysis, Supplier Quality
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