Technical Writer

Infotree Global Solutions; North Haven (CT); On-site; USD 70,000 - 90,000; Full time

Job summary

A medical technology company is seeking a Quality Engineer II to support risk assessments, design change quality reviews, and address quality issues throughout the medical device lifecycle. The ideal candidate will possess a Bachelor's or Master's degree and relevant experience, demonstrating skills in technical writing, data analysis, and project management. This position requires collaboration across engineering, manufacturing, and quality assurance functions to maintain high standards and improve processes.

Qualifications

• Minimum of 2 years of relevant experience or 0 years with advanced degree.
• Practical knowledge within the job area obtained through education and experience.

Responsibilities

• Develop, modify, and maintain quality standards and protocol for products.
• Collaborate with engineering to ensure quality standards.
• Conduct quality assurance tests and perform statistical analysis.

Skills

Technical writing

Data analysis

Project management

Education

Baccalaureate degree or Master's degree

Job description

If you currently have any of the following work authorization statuses, please apply for this position: U.S. Citizen, Green Card, GC EAD, H4 EAD, Initial CPT, or L2.

Job Description

The duties related to the Quality Engineer II role require knowledge and experience in Medical Device industry to support or perform risk assessments, design change quality reviews, and support potential product quality issues in released product portfolio. This encompasses all aspects of a medical device’s lifecycle such as design, manufacturing, distribution and obsolescence. The diversity of duties and skills may include technical writing (Design Failure Mode Effect Analysis, and other related technical documentation) to creative and critical thinking, working with diverse teams in resolving quality issues and process improvements. The duties are complex as depending on the complexity of the issues, all duties and projects are often performed in parallel.

Top 3 technical skills required for the role

• technical writing
• data analysis
• project management

Education Required / Years’ Experience Required

Baccalaureate degree and minimum of 2 years of relevant experience OR Master\'s degree with a minimum of 0 years relevant experience.

Responsibilities may include the following and other duties may be assigned.

Develops, modifies, applies, and maintains quality standards and protocol for processing materials into partially finished or finished materials product. Collaborates with engineering and manufacturing functions to ensure quality standards are in place. Devises and implements methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment. Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications. Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements. May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.

Required Knowledge and Experience

Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.

Regards,