Description:
Baebies is a medical device company that develops and commercializes newborn screening and near-patient testing products for children and adults to enable early disease detection and comprehensive diagnosis. Guided by the vision that everyone deserves a healthy start," our mission is to save lives and make lives better for all by bringing new technologies, new tests, and new hope to children, parents, adult patients, and healthcare professionals worldwide.
Job purpose
The Senior Quality 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.
Duties and 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
Requirements:
Qualifications
Education:
- BS in engineering or life science field.
Experience:
- 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.
Skill/abilities:
- Strong statistical data analysis knowledge
- Read, interpret, understand, and implement regulations and regulatory requirements
- Technical writing, including reports, and protocols
- Excellent verbal and written communication skills
- Ability to work with all levels of an organization
- Project management
- Work independently with minimal supervision
Working conditions
General Office Environment
Physical requirements
Ability to lift up to 20 pounds
Direct reports
None
Compensation & Benefits
Baebies offers a dynamic and welcoming work environment surrounded by intelligent, driven, and creative people. Guided by the vision that everyone deserves a healthy start, our team is devoted to our customers and to advancing technology in early disease detection and comprehensive diagnosis. At Baebies, we look for people who are innovative, dedicated to our mission, and constantly striving to improve the status quo.
In addition to competitive, market-driven compensation, Baebies provides 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.
Baebies, Inc. is an equal opportunity employer. NO RECRUITERS OR AGENCIES, PLEASE.
Compensation details: 00 Yearly Salary
PIa7938ba09ca6-7046