Senior Quality Assurance Engineer Specialist
5 days ago
Senior Quality Assurance Engineer Specialist
Job Description:We are seeking a highly experienced and skilled Senior Quality Assurance Engineer to join our team at Baebies Inc. in the medical device industry.
About the Role:The Senior Quality Assurance Engineer will be responsible for ensuring compliance with FDA, IVDD, IVDR, and ISO 13485 regulations through implementation and maintenance of quality management system design and improvement activities to assure product quality and safety.
Key Responsibilities:- Ensure FDA,IVDD, IVDR, ISO 13485 compliance
- Conduct internal audits and manage external audits
- Assist in the management of the corrective and preventive action system, initiate, track, close, review and maintain logs and metrics
- Administration of non-conforming material and deviation processes
- Support document control administration, including review and routing of change orders, filing records, and training need employee on the use of Unipoint and Arena systems.
- Pre-Market Quality Assurance (Design and Process Documentation Review)
- Provide support for equipment and process validation
- Manage risk management process throughout product life cycle
- Compile, analyze, trend and present QMS metrics
- Gather and prepare data for quality meetings and management review meetings
- Work closely with Regulatory to ensure labeling meets international regulatory requirements
- 7+ years' experience in Quality Assurance in the medical device industry
- 5+ years' experience with FDA and ISO 13485 quality systems regulations and guidelines.
- Performance of Internal audits
- Product and process related validation
- Design and development process and DHF requirements
- Software validation activities for medical devices
- Experience in small to medium size medical company is preferred.
- BS in engineering or life science field.
$100,000 per year, estimated based on market trends and industry standards.
Baebies Inc. Offers:A dynamic and welcoming work environment surrounded by intelligent, driven, and creative people.
We provide a comprehensive employee benefits package including:
• 100% employee premiums for Medical & Vision coverage
• 100% employee and family premiums for Dental coverage
• 401K available
• Stock Options
• 4 Weeks PTO
• 14 Paid Holidays per year
• Paid Employee Life Insurance
• Onsite free gym membership & classes
• Discount Pet & Legal Insurance
• Fertility & Family Support
• Much more
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