Quality Engineer

Shift: Mon-Fri First Shift
Duration: 06 Months
Pay range: $29.00 Hourly - $29.00 Hourly
Onsite Job

Description:

ROLE AND RESPONSIBILITIES

• Actively partner with Manufacturing departments, providing tactical Quality support to the teams

• Investigate, analyze and correct non-conformances (internal, external and systemic issues)

• Lead root cause analysis, implement/provide corrective actions and ensure their effectiveness

• Collect, analyze, and present Quality data

• Create quality documents aligned to regulations and practices, revise quality documentation to better define, improve, or clarify practices, process and/or product quality

• Participate in change control activities for documents and manufacturing processes

• Support eDMS system with processing document change requests related to Quality System documents
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• Laboratory experiments, as required

• Other duties may be assigned, as required

• Travel requirement: 0-10%

QUALIFICATIONS AND EDUCATION REQUIREMENTS

• 1+ year experience in a Quality Engineering position – familiarity with and execution of principles within Certified Quality Engineer (ASQ CQE) Body of Knowledge

• BS Biology, Chemistry, or Engineering (Chemical, Biomedical, Industrial, Mechanical or Quality) or demonstrated equivalent work experience in the Quality Engineering area pertaining to a scientific industry

• Knowledge in standards such as ISO 13485:2016 Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes, ISO 9001:2015 – Quality Management Systems, and ISO 14971 Medical Devices – Risk Management.

PREFERRED SKILLS

• Knowledge of Operations and manufacturing processes

• Scientific laboratory experience highly desired

• Familiarity with enterprise software systems including ERPs, electronic document control systems, CAPA and training software packages

• Able to motivate and positively influence peers

• Ability to read, analyze, and interpret common scientific and technical data and QMS standards

• Ability to resolve rapidly common inquiries or complaints from internal and/or external customers and regulatory agencies

• Ability to effectively present information to groups of employees, site leadership, and customers

• Ability to define problems, collect data, establish facts, and draw valid conclusions

Employee Benefits:
At Lance Soft, full time regular employees who work a minimum of 30 hours a week or more are entitled to the following benefits:

• Four options of medical Insurance
• Dental and Vision Insurance
• 401k Contributions
• Critical Illness Insurance
• Voluntary Permanent Life Insurance
• Accident Insurance
• Other Employee Perks

About Lance Soft
Lance Soft 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.