Quality Engineer II

Job Description

Job Description

Title: Quality Engineer II

Contract Duration: 12+months

TECHNICAL SKILLS

Must Have

• 1-3 years of Medical Device industry experience, Familiar with FDA 21 CFR Part 820, EU 217/745 (EU MDR),
• Familiar with these standards: ISO 13485, ISO 14971, IEC 60601, Knowledge of Microsoft Office Applications (Word, Excel, Access, and PowerPoint) and Windows OS.
• 1. Investigation and root cause analysis skills,
• 2. Technical writing knowledge
• 3. Organization and Communication skills
• 4. Process Validation and Computer software validation knowledge

Responsibilities:

• Will be responsible for assisting with the implementation of new projects in a manufacturing environment.
• Duties may include creating and revising work instructions, developing and executing validations, analysis of failures to create corrective actions, pFMEA revisions, working closely with Senior Engineers to develop processes, training users in new processes, and equipment validations.
• Candidate must have strong communication skills, critical thinking skills, able to work autonomously and a strong focus on time management.
• Candidate must be able to work in multiple software systems including Microsoft Office, Agile PLM, SAP and others as needed.
• Experience with Excel Macros is a plus.
• 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.

LanceSoft is rated as one of the largest staffing firms in the US by SIA. Our mission is to establish global cross-culture human connections that further the careers of our employees and strengthen the businesses of our clients. We are driven to use the power of our global network to connect businesses with the right people, and people with the right businesses without bias. We provide Global Workforce Solutions with a human touch.

Company Description

LanceSoft is rated as one of the largest staffing firms in the US by SIA. Our mission is to establish global cross-culture human connections that further the careers of our employees and strengthen the businesses of our clients. We are driven to use the power of our global network to connect businesses with the right people, and people with the right businesses without bias. We provide Global Workforce Solutions with a human touch.